Towards Implementation of Universal Newborn Hearing Screening in Kenya

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for infants aged 5 to 7 months, with or without HIV exposure, and their biological mothers. Infants will have hearing and ear checks with smartphone and standard devices over 6 months.

Életkor

Infants: 5 to 7 months. Mothers: at least 18 years old.

Nem

Infants of any sex can join. The parent must be the infant's biological mother.

Biomarker vagy leletérték

The mother must be willing to share her HIV status, confirmed by medical records.

A részvétel fő kizáró okai

• Not willing to give contact details so the study team can reach the family
• Infant has no open ear canal (at least one open ear canal is needed)
• Mother not planning to live in the study area for the next 6 months

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat csoportja

• Hearing and ear health screeningA vizsgált kezelés

  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.