Neonatal Hearing Screening at Neonatal Intensive Care Unit

Hearing Loss Clinical Trial

Official title:

Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03716362
• Other study ID #: NHS
• Status: Not yet recruiting
• Start date: November 1, 2018
• Est. completion date: November 2019

Study information

• Verified date: October 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Otoacoustic emissions device
as a screening tool for Auditory brainstem response

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit		1 year