Long-Term Outcomes of Children With Congenital CMV in New York State (PROACTIVE NYS)

Stony Brook University

Status: Enrolling

Conditions: Congenital CMV Infection; Sensorineural Hearing Loss

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06226558

75N94021D00018-75N94023F00001

Details and patient eligibility

About

PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms.

In particular, our study will provide new information about many facets of congenital CMV, including:

• Developmental, hearing, neurologic, and vision outcomes
• The spectrum and timing of symptoms
• The impact congenital CMV has on the baby and its family
• How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV

Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.

Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.

Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 4 patient groups

Category 1: Confirmed cCMV infection identified by NYS newborn screen

Description:

Infants who have both a positive cCMV NYS newborn screen AND are positive for cCMV on confirmatory testing

Category 2: Confirmed cCMV infection NOT identified by NYS newborn screen

Description:

Infants who have both a NEGATIVE cCMV NYS newborn screen AND are found to have cCMV on confirmatory testing

Category 3: False-positive cCMV NYS newborn screen

Description:

Infants who have both a positive cCMV NYS newborn screen AND are NEGATIVE for cCMV on confirmatory testing

Category 4: Premature infants with confirmed CMV infection on late positive NBS

Description:

Infants who are: (a) born prior to 37 weeks gestation AND (b) cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND (c) Have a positive cCMV confirmatory test obtained within 14 days of a positive NYS newborn screen