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

Sensorineural Hearing Loss Clinical Trial

— PROACTIVE NYS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226558
• Other study ID #: 75N94021D00018-75N94023F00001
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Stony Brook University
• Contact: Andrew Handel, MD
• Phone: 631-444-7692
• Email: Andrew.handel[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Congenital CMV Infection
• Cytomegalovirus Infections
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Locations

Country	Name	City	State
United States	Stony Brook Children's Hospital	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Frontier Science & Technology Research Foundation, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Congenital CMV infection rate	To determine the rate of confirmed congenital CMV in a statewide cohort	Study initiation to 1 year time point
Secondary	cCMV neonatal sensorineural hearing loss	Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing	Through 4 weeks old
Secondary	cCMV antiviral therapy utilization	Frequency of antiviral prescriptions	2 years
Secondary	cCMV acquired sensorineural hearing loss	Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing	2 years
Secondary	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
Secondary	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

External Links

•   PROACTIVE NYS Website