Cytomegalovirus Infection in Pregnancy: Prevention, Presentation, Management and Neonatal Outcomes.
Megan H Pesch, Natalie A Saunders, Samia Abdelnabi
https://pubmed.ncbi.nlm.nih.gov/34031974Actively Recruiting
Age: 0Days - 1Year
All Genders
ID06226558
Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
Led by Stony Brook University · Updated on 2025-05-13
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Stony Brook University
Lead Sponsor
F
Frontier Science & Technology Research Foundation, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a long-term follow-up study of infants in New York State who test positive for congenital Cytomegalovirus infection (cCMV) through newborn screening. This observational study aims to understand the range of symptoms caused by cCMV, from severe cases to those without symptoms, and to learn about developmental, hearing, neurologic, and vision outcomes, as well as the impact on families and infection rates. The study is sponsored by Stony Brook University and focuses on infants born during the cCMV newborn screening pilot program.
CONDITIONS
Brief Title
Long-Term Outcomes of Children With Congenital CMV in New York State
Who Can Participate
Age: 0Days - 1Year
All Genders
Eligibility Criteria
You may qualify if you...
- Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)
- cCMV evaluation provided by a designated NYS cCMV clinical referral site
- Family willing and able to complete all study procedures
- Study participants meet criteria for one of the following categories:
- Category 1: Positive cCMV NYS newborn screen AND positive confirmatory test
- Category 2: Negative cCMV NYS newborn screen AND positive confirmatory test
- Category 3: Positive cCMV NYS newborn screen AND negative confirmatory test
- Category 4: Infant born before 37 weeks gestation AND cCMV positive on any NYS newborn screen collected before 44 weeks gestational age AND positive confirmatory test within 14 days of positive newborn screen
You will not qualify if you...
- Neonate whose parents refuse participation in the long-term follow-up study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 2 years
Participants with confirmed or suspected congenital CMV infection are observed over time to assess infection rates, hearing loss, neurodevelopmental outcomes, and quality of life.
Regular visits for follow-up assessments through 2 years
Trial Site Locations
Total: 1 location
1
Stony Brook Children's Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
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Research Team
A
Andrew Handel, MD
S
Sharon Nachman, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy.
William D Rawlinson, Suresh B Boppana, Karen B Fowler...
https://pubmed.ncbi.nlm.nih.gov/28291720Congenital cytomegalovirus infection.
Karen B Fowler, Suresh B Boppana
https://pubmed.ncbi.nlm.nih.gov/29503048