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De klinische studie NCT06226558 (PROACTIVE NYS) voor Congenital CMV Infection, Perceptief gehoorverlies is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Long-Term Outcomes of Children With Congenital CMV in New York State (PROACTIVE NYS) 1.000 Langdurige follow-up

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De klinische studie NCT06226558 (PROACTIVE NYS) is een observationeel studie bij Congenital CMV Infection, Perceptief gehoorverlies met de status rekruterend. Het doel is om 1.000 deelnemers te includeren vanaf 1 februari 2024. De studie wordt geleid door Stony Brook-universiteit en de voltooiing is gepland op 1 oktober 2026. Laatste update op ClinicalTrials.gov: 13 mei 2025.
Beknopte samenvatting
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 ...

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Officiële titel

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

Aandoeningen
Congenital CMV InfectionPerceptief gehoorverlies
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • PROACTIVE NYS
  • 75N94021D00018-75N94023F00001
NCT-ID
NCT06226558
Startdatum (Werkelijk)
2024-02-01
Laatste update geplaatst
2025-05-13
Verwachte einddatum
2026-10-01
Inschrijving (Geschat)
1.000
Studietype
Observationeel
Status
Rekruterend
Trefwoorden
Congenital CMV
cCMV
Congenital infection
Sensorineural hearing loss
SNHL
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
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
N.v.t.
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
N.v.t.
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
N.v.t.
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
N.v.t.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Congenital CMV infection rate
To determine the rate of confirmed congenital CMV in a statewide cohort
Study initiation to 1 year time point
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
cCMV neonatal sensorineural hearing loss
Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Through 4 weeks old
cCMV antiviral therapy utilization
Frequency of antiviral prescriptions
2 years
cCMV acquired sensorineural hearing loss
Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
2 years
cCMV neurodevelopmental outcomes
Neurodevelopmental abnormalities as measured by Bayley Scales of Infant \& Toddler Development-III. The Bayley-III includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales. Age-normalized scores are calculated for each domain, with a lower score indicating greater impairment.
2 years
cCMV-related quality of life
Quality of life score as determined by the Pediatric Quality of Life Inventory Infant Scales (PedsQL). The PedsQL Infant Scales consist of parent-reported psychosocial health symptoms. A higher score on the PedsQL indicates more severe psychosocial health symptoms.
2 years
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Kind
Minimumleeftijd
0 Days
Geslachten die in aanmerking komen voor de studie
Allen
  • 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

  • Neonate whose parents refuse participation in the long-term follow-up study
Stony Brook University logoStony Brook-universiteit
Frontier Science & Technology Research Foundation, Inc. logoFrontier Science & Technology Research Foundation, Inc.
Verantwoordelijke instantie
Andrew S Handel, Hoofdonderzoeker, Physician, Stony Brook University
Centraal Contactpersoon
Contact: Andrew Handel, MD, 631-444-7692, [email protected]
Contact: Sharon Nachman, MD, 631-444-7692, [email protected]
1 Studielocaties in 1 landen

New York

Stony Brook Children's Hospital, Stony Brook, New York, 11794, United States
Andrew Handel, MD, Contact, 631-444-7692, [email protected]
Andrew Handel, MD, Hoofdonderzoeker
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