- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03881514
Mode of Delivery on Newborn Hearing Test
The Effect of Mode of Delivery on Automated Auditory Brainstem Response (AABR) Test
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate.
newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- records of birth process and
- pregnancy test results of newborns.
Exclusion Criteria:
- newborn;
- She was in a neonatal intensive care,
- congenital / chromosomal anomaly,
- undergoing congenital cmv infection,
- facial / ear deformity,
- families with hearing problems,
- those with hyperbiliromyemia,
- <12 hours after delivery,
- maternal infection,
- dm,
- recurrent abortion,
- smoking,
- plesanta previa,
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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newborn hearing screening results
Time Frame: 1 week after delivery
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hearing test results of newborns. The test results will be grouped according to the type of birth. The effect of the type of delivery on hearing test results will be investigated. The relationship between vaginal route and cesarean section and hearing test will be the first results. hearing test results were evaluated separately for the right and left ear as 'passed the test' and 'left test'. |
1 week after delivery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.9.16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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