Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT06226558
Eligibility Criteria:
Inclusion Criteria:
* 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 four categories:
* 1\. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive
* 2\. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive
* 3\. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test
* 4\. Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS
Exclusion Criteria:
* Neonate whose parents refuse participation in the long-term follow-up study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
1 Year
Study:
NCT06226558
Study Brief:
Protocol Section:
NCT06226558