Long-Term Outcomes of Children With Congenital CMV in New York State

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Screening for Congenital Cytomegalovirus Infection in Newborns

NCT02683096

Cytomegalovirus Infections

COMPLETED

Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening

NCT02139423

Congenital Cytomegalovirus Infection

COMPLETED NA

Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening

NCT07335874

Neonatal Hearing Loss

RECRUITING

Cytomegalovirus (CMV) Infection in Pregnancy

NCT00194155

Pregnancy Complications Cytomegalovirus Infection

COMPLETED

Cytomegalovirus (CMV) Infection in Amniotic Fluid

NCT00194142

Pregnancy Complications Cytomegalovirus Infections

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital CMV Infection Sensorineural Hearing Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Category 1: Confirmed cCMV infection identified by NYS newborn screen

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Category 3: False-positive cCMV NYS newborn screen

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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