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Towards Implementation of Universal Newborn Hearing Screening in Kenya
Sponsor: University of Washington
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.
Official title: mHealth OAE: Towards Implementation of Universal Newborn Hearing Screening in Kenya - R33 Phase (mTUNE-R33)
Key Details
Gender
All
Age Range
5 Months - 7 Months
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-09-24
Completion Date
2028-09
Last Updated
2026-10-16
Healthy Volunteers
Yes
Interventions
Hearing and ear health screening
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.
Locations (1)
Mathare North Health Centre
Nairobi, Kenya