Neonatal Hearing Screening at Neonatal Intensive Care Unit

Withdrawn

• Conditions: Hearing Loss
• Interventions: Device: Otoacoustic emissions device

• Registration Number: NCT03716362
• Lead Sponsor: Assiut University

Brief Summary

Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.

Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment.

One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.

Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-21
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-23
• Study Start: 2018-11-01
• Primary Completion: 2019-10
• Study Completion: 2019-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Neonates of both sexes.
• Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
• Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion.

Exclusion Criteria

• neonates whose parent refuse to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates who will be admitted at Neonatal Intensive Care Unite	Otoacoustic emissions device	-

Primary Outcome Measures

Name	Time	Method
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit	1 year

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt