Neonatal Hearing Screening in Assiut Hospital

August 19, 2017 updated by: Nesma Gamal, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

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 .

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neonates who admitted at neonatal intensive care unit

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal hearing screening
Time Frame: 6months
number of neonates who failed to pass emissions
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Nafesa Hs Rafat, Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

August 12, 2017

First Submitted That Met QC Criteria

August 12, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 19, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assuit

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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