N/A N=1,098 Randomized Prevention

Communities Helping the Hearing of Infants by Reaching Parents

Congenital Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT03875339 ↗

Enrolled (actual)

1,098

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) — 378; 336 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Navigator Guidance (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Matthew Bush, MD
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)	378; 336	—

Summary

Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss receive timely care by using a patient navigator, who is someone who teaches and provides emotional/social support for the families of these children. The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.

Eligibility Criteria

Inclusion Criteria

Inclusion criteria for parent-infant dyads:

Infant failed a hearing screening in one or both ears before postnatal hospital discharge
Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
Parent able to speak either English or another language using Cyracom phone interpreting services.

Exclusion Criteria

Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03875339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.