Clinical Sites

Clinic:
1 Children's Way
Little Rock, Arkansas 72202

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
6701 Fannin Street
Houston, Texas 77030

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
UBHT Education Centre, Level 6, Upper Maudlin Street
Bristol, England BS2 8AE

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
8200 Dodge Street
Omaha, Nebraska 68114

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
13123 E 16th Avenue
Aurora, Colorado 80045

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1201 W La Veta Avenue
Orange, California 92868

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
8915 W Connell Court
Milwaukee, Wisconsin 53226

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Clinic:
111 Michigan Avenue NW
Washington, District of Columbia 20010

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.


Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
801 7th Avenue
Fort Worth, Texas 76104

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
2015 Uppergate Drive
Atlanta, Georgia 30322

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
Bordesley Green
Birmingham, England B95SS

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
30 Guilford Street
London, England WC1N 1EH

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1901 West Harrsion Street
Chicago, Illinois 60612

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
3101 Wyman Park Drive
Baltimore, Maryland 21218

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1000 Blythe Boulevard
Charlotte, North Carolina 28203

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1501 Kings Highway
Shreveport, Louisiana 71103

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
171 Ashley Avenue
Charleston, South Carolina 29425

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
700 Childrens Drive
Columbus, Ohio 43205

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Clinic:
700 Children's Drive
Columbus, Ohio 43205-2664

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
Limbert House, North Manchester General Hospital
Manchester, England M8 5RB

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
Level 2 Oxford Children’s Hospital, Headley Way
Headington, Oxford OX3 9DU

Studies:

There are no studies at this time

Clinic:
593 Eddy Street
Providence, Rhode Island 2903

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
Old Children’s Outpatient Building, Queen Victoria Road
Newcastle upon Tyne, England NE1 4LP

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
750 E Adams Street
Syracuse, New York 13210

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
4800 Sand Point Way NE
Seattle, Washington 98105

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
Sheffield Children's NHS Foundation Trust, Western Bank
Sheffield, England S10 2TH

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
University Hospital Southampton NHS Trust, Tremona Road
Southampton, England SO16 6YD

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
Blackshaw Road
London, England SW17 0QT

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
254 Easton Avenue
New Brunswick, New Jersey 8901

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
450 Serra Mall
Stanford, California 94305

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1600 7th Avenue S. Children's Harbor, Suite 303
Birmingham, Alabama 35233

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

The purpose of this study is to evaluate at-risk babies to determine the appropriate dose of oral valacyclovir comparable to the intravenous (IV) acyclovir doses typically used to treat babies with neonatal Herpes Simplex Virus (HSV) disease. IV acyclovir is best for the treatment of babies who already have HSV disease, but it is not ideal to prevent HSV disease because there are risks associated with IV use in babies. Valacyclovir is metabolized to become acyclovir, and although it has been studied in babies as young as one month old, there are no dosing recommendations for those less than three months old. This study focuses on at-risk babies whose mothers have a history of genital HSV infection and have been taking oral acyclovir or valacyclovir for several weeks before delivery. By studying the blood concentration, metabolism, clearance and safety profile of valacyclovir in infants less than one month old, we will determine the best dose of valacyclovir to prevent HSV infection when babies are exposed to it at birth. We will also inform larger studies using valacyclovir to treat neonatal HSV disease.

Congenital cytomegalovirus (CMV) infection is common and the leading viral cause of sensorineural hearing loss (SNHL) and mental retardation in infants. Despite current treatment options, babies with symptomatic congenital CMV disease are still at risk for hearing loss and neurologic deficits. Letermovir is the first new antiviral treatment of CMV to be licensed in over two decades. Two groups will be enrolled, and letermovir will be administered for 14 days in subjects in both groups. All subjects also will receive valganciclovir as standard of care. Group 1 (n=4) will be given a single dose based on their weight of letermovir on Study Day 0, with a full PK profile obtained over the next 24 hours to verify that the selected dose does not exceed the targeted exposure. Blood specimens will be shipped within approximately 24 hours to the UAB Pharmacokinetic Lab and processed in real time in order to get results back to the study site within an anticipated 7 days. If the drug levels are acceptable, the subject begin a 14-day course of once daily oral letermovir. If the dose is not acceptable, the dose will be adjusted down in 2.5mg increments. Once 4 subjects have been enrolled in group 1, the data and safety monitoring board will review all safety and drug level data. If no concerns are identified, then 8 additional subjects will be enrolled in group 2. The group 2 subject will start the 14 day course of study medication. The dose for group will be based on the data reviewed by the safety committee for the group 1 subjects.

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
501 East Broadway, Suite 210
Louisville, Kentucky 40202

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
420 Delaware Street
Minneapolis, Minnesota 55455

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
2500 N State Street
Jackson, Mississippi 39216

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
42nd and Emile Street
Omaha, Nebraska 68198

Studies:

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
500 Joseph C. Wilson Boulevard
Rochester, New York 14627

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1601 Center Street, Suite 1017 C
Mobile, Alabama 36604

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
17 Davis Boulevard
Tampa, Florida 33606

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1985 Zonal Avenue
Los Angeles, California 90089-9121

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
5323 Harry Hines Boulevard
Dallas, Texas 75390

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1211 Medical Center Drive
Nashville, Tennessee 37232

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.

Clinic:
1 Brookings Drive
St. Louis, Missouri 63130

Studies:

Recruiting

The purpose of this study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health over time. Enterovirus (EV) or human parechovirus (HPeV) are very common viruses that can cause neonatal viral sepsis. Information gained from this study may guide diagnosis and treatment of babies with neonatal viral sepsis in the future. This study will observe babies with neonatal EV or HPeV sepsis to assess and characterize the complications affecting them. The study will also identify key clinical measurements and tests that help predict the health outcomes of children with neonatal EV and HPeV sepsis. Further, although EV and HPeV are common causes of neonatal viral sepsis, this study seeks to identify other unknown viruses linked to neonatal viral sepsis. The information generated by this study will lay the foundation for clinical trial studies of antiviral drugs to treat neonatal viral sepsis.

Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from previous CASG studies and patients treated clinically for cCMV. The goal is to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty.