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Recruiting NCT06226558

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

— Observational Congenital CMV Infection Sensorineural Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Congenital CMV Infection, Sensorineural Hearing Loss. Basic parameters: 0 Days — 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State

Overview

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.

Primary outcome measures

  • Congenital CMV infection rate [Time frame: Study initiation to 1 year time point]
Secondary outcome measures (5)
  • cCMV neonatal sensorineural hearing loss [Time frame: Through 4 weeks old]
  • cCMV antiviral therapy utilization [Time frame: 2 years]
  • cCMV acquired sensorineural hearing loss [Time frame: 2 years]
  • cCMV neurodevelopmental outcomes [Time frame: 2 years]
  • cCMV-related quality of life [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Stony Brook Children's Hospital — Stony Brook

Publications

  • 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 34031974
  • 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. PMID 28291720
  • 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 29503048

Identifiers

NCT: NCT06226558 · 75N94021D00018-75N94023F00001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗