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Clinical Trials/NCT03251638
NCT03251638
Unknown
N/A

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

Assiut University0 sites300 target enrollmentMarch 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neonatal Hearing Impairment
Sponsor
Assiut University
Enrollment
300
Primary Endpoint
Neonatal hearing screening
Last Updated
8 years ago

Overview

Brief Summary

Hearing loss is one of the most common congenital anomalies. Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language.Auditory brainstem response , otoacoustic emissions testing have all been used in newborn hearing-screening programs

Detailed Description

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 . Currently, 2 types of evoked otoacoustic emissions measurements are used for newborn hearing screening: transient evoked otoacoustic emissions and distortion product otoacoustic emissions . Provided that the patient's middle ear function is normal, these measurements can be used to assess cochlear function for the 500-6000 Hz frequency range. The presence of evoked otoacoustic emissions responses indicates hearing sensitivity in the normal to near-normal range . The Auditory brainstem response test records brainstem electrical activity in response to sounds presented to the infant via earphones. In contrast to the otoacoustic emissions test, the The Auditory brainstem response evaluates the auditory pathway from the external ear to the level of the brainstem, enabling diagnosis of auditory neuropathy, which is a less common cause of hearing impairment .

Registry
clinicaltrials.gov
Start Date
March 2018
End Date
November 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nesma Gamal

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

Assiut University

Eligibility Criteria

Inclusion Criteria

  • A) Neonates of both sexes. (B) Neonates with the following risk factors according to the Joint Committee on Infant Hearing 2000 Position Statement:
  • In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
  • Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion, persistent pulmonary hypertension of the newborn associated with mechanical ventilation, and conditions requiring the use of extracorporeal membrane oxygenation
  • Low birth weight (1500-1800)grams

Exclusion Criteria

  • • Absence of high risk factors in the neonates.

Outcomes

Primary Outcomes

Neonatal hearing screening

Time Frame: 6months

number of neonates who failed to pass emissions

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