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NCT07879326
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Conditions: Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Sex: All
Ages: 5 Months – 7 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 400
Sponsor: University of Washington
Location: Mathare North Health Centre Nairobi
Summary
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.
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
Source: ClinicalTrials.gov (NCT07879326). StuddyBuddy aggregates publicly available trial information.