NCT06226558

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2024Oct 2026

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

December 19, 2023

Last Update Submit

May 12, 2025

Conditions

Congenital CMV InfectionSensorineural Hearing Loss

Keywords

Congenital CMVcCMVCongenital infectionSensorineural hearing lossSNHL

Outcome Measures

Primary Outcomes (1)

  • Congenital CMV infection rate

    To determine the rate of confirmed congenital CMV in a statewide cohort

    Study initiation to 1 year time point

Secondary Outcomes (5)

  • cCMV neonatal sensorineural hearing loss

    Through 4 weeks old

  • cCMV antiviral therapy utilization

    2 years

  • cCMV acquired sensorineural hearing loss

    2 years

  • cCMV neurodevelopmental outcomes

    2 years

  • cCMV-related quality of life

    2 years

Study Arms (4)

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

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

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

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

Eligibility Criteria

Age0 Days - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants referred by the New York State Newborn Screen Program to a clinical care referral site for a positive congenital CMV test will be approached for enrollment in PROACTIVE NYS. In addition, infants who are identified with cCMV as part of routine clinical care during the study period will be eligible to enroll in PROACTIVE NYS.

You may qualify if:

  • 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:
  • \. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive
  • \. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive
  • \. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test
  • \. 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

You may not qualify if:

  • Neonate whose parents refuse participation in the long-term follow-up study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook Children's Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (3)

  • Pesch MH, Saunders NA, Abdelnabi S. Cytomegalovirus Infection in Pregnancy: Prevention, Presentation, Management and Neonatal Outcomes. J Midwifery Womens Health. 2021 May;66(3):397-402. doi: 10.1111/jmwh.13228. Epub 2021 May 24.

    PMID: 34031974BACKGROUND

  • Rawlinson WD, Boppana SB, Fowler KB, Kimberlin DW, Lazzarotto T, Alain S, Daly K, Doutre S, Gibson L, Giles ML, Greenlee J, Hamilton ST, Harrison GJ, Hui L, Jones CA, Palasanthiran P, Schleiss MR, Shand AW, van Zuylen WJ. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017 Jun;17(6):e177-e188. doi: 10.1016/S1473-3099(17)30143-3. Epub 2017 Mar 11.

    PMID: 28291720BACKGROUND

  • Fowler KB, Boppana SB. Congenital cytomegalovirus infection. Semin Perinatol. 2018 Apr;42(3):149-154. doi: 10.1053/j.semperi.2018.02.002. Epub 2018 Mar 2.

    PMID: 29503048BACKGROUND

Related Links

MeSH Terms

Conditions

Cytomegalovirus InfectionsHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew Handel, MD

CONTACT

631-444-7692Andrew.handel@stonybrookmedicine.edu

Sharon Nachman, MD

CONTACT

631-444-7692sharon.nachman@stonybrookmedicine.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 26, 2024

Study Start

February 1, 2024

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)