Clinical trial NCT06226558: Long-Term Outcomes of Children With Congenital CMV in New York State
Official title: Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital CMV Infection
Sensorineural Hearing Loss
Keywords: Congenital CMV
cCMV
Congenital infection
Sensorineural hearing loss
SNHL
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Frontier Science & Technology Research Foundation, Inc.
First posted: 2024-01-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


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

Primary outcomes:
measure: Congenital CMV infection rate
timeFrame: Study initiation to 1 year time point
Secondary outcomes:
measure: cCMV neonatal sensorineural hearing loss
timeFrame: Through 4 weeks old
measure: cCMV antiviral therapy utilization
timeFrame: 2 years
measure: cCMV acquired sensorineural hearing loss
timeFrame: 2 years
measure: cCMV neurodevelopmental outcomes
timeFrame: 2 years
measure: cCMV-related quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Children's Hospital
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.