Study Stopped
no participant
Neonatal Hearing Screening at Neonatal Intensive Care Unit
1 other identifier
observational
N/A
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJuly 31, 2024
July 1, 2024
11 months
October 21, 2018
July 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit
1 year
Study Arms (1)
Neonates who will be admitted at Neonatal Intensive Care Unite
Interventions
as a screening tool for Auditory brainstem response
Eligibility Criteria
This study will conduct on neonates who will be admitted at intensive care unit
You may qualify if:
- 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.
You may not qualify if:
- neonates whose parent refuse to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women Health Hospital - Assiut university
Asyut, 71111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
October 21, 2018
First Posted
October 23, 2018
Study Start
November 1, 2018
Primary Completion
October 1, 2019
Study Completion
November 1, 2019
Last Updated
July 31, 2024
Record last verified: 2024-07