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Neonatal Hearing Screening at Neonatal Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03716362
Recruitment Status : Unknown
Verified October 2018 by Mohammed Khairy Ali, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Mohammed Khairy Ali, 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 .

Condition or disease Intervention/treatment
Hearing Loss Device: Otoacoustic emissions device

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Neonates who will be admitted at Neonatal Intensive Care Unite Device: Otoacoustic emissions device
as a screening tool for Auditory brainstem response

Primary Outcome Measures :
  1. Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This study will conduct on neonates who will be admitted at intensive care unit

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03716362

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Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University Identifier: NCT03716362    
Other Study ID Numbers: NHS
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases