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RECRUITING Not applicable ClinicalTrials.gov

Towards Implementation of Universal Newborn Hearing Screening in Kenya

Sponsor: University of Washington • ClinicalTrials.gov ID: NCT07879326

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Hearing and ear health screening (Device)
    Hearing will be screened using smartphone and conventional devices that detect otoacoustic emissions. Ear health will be screened using a smartphone device that uses acoustic reflectometry to detect middle ear fluid.

Eligibility criteria

Inclusion Criteria: * Is at least 18 years old * Is a biological mother for the infant participant * Willing to disclose HIV status with confirmation from medical record * Planning to reside in the study catchment for the next 6 months Infants must meet all of the following criteria: * Age 5 to 7 months * at least one patent ear canal Exclusion Criteria: • Unwilling to provide locator information for contact

Conditions

Hearing Loss, Bilateral or Unilateral Otitis Media With Effusion in Children

Locations

  • Mathare North Health Centre — Nairobi, Kenya
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record