Towards Implementation of Universal Newborn Hearing Screening in Kenya

Study acronym: mTUNE-R33
StatusRecruiting
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
The goal of this observational study is to learn if smartphone hearing screening devices can help to understand the role of ear infections in hearing loss in infants with HIV exposure. The main questions it will answer are 1) What is the screening accuracy of smartphone hearing screening? 2) What is the incidence of ear infections and of abnormal hearing screening findings in infants with and without HIV exposure? Researchers will follow infants with and without HIV exposure for 6 months and will use smartphone and conventional hearing and ear health screening devices at the same time to see if the smartphone devices can help detect ear infections. Parent and infant participants will visit the clinic 3 times over 6 months. At these visits, infants will have hearing and ear health checked using smartphone and conventional devices.
Trial Details
NCT Number NCT07879326
Lead Sponsor University of Washington
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Related terms Hearing Loss, Otitis Media with Effusion
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov