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NCT05152589 Clinical Trial

Maternal Diabetes in Newborns With Hearing Loss

Hearing Loss Clinical Trial

— GDM  

Official title:
Newborn Hearing Loss

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05152589
Other study ID # E2-21-1070
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date June 30, 2023

Study information
Verified date November 2021
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to investigate the presence and characteristics of maternal diabetes as a risk factor in newborns with hearing loss. Hearing loss is one of the most common congenital anomalies among newborns. The newborn hearing screening program is important for early diagnosis in newborns with hearing loss.Gestational diabetes, on the other hand, is a metabolic disease that occurs during pregnancy and can cause complications as in other diabetes mellitus patients. Despite our knowledge of major complications, the effect of the hyperglycemic intrauterine environment on hearing outcomes has not been adequately studied. The inner ear does not store energy, so it has a particularly high sensitivity to altered blood sugar and insulin. Altered inner ear metabolism leads to auditory and balance disorders. There is no study in the literature comparing uncomplicated gestational diabetes and pregestational diabetes as a prenatal complication that poses a risk of hearing loss.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: - POSTNATAL AGE BETWEEN 0-28 DAYS - BIRTH WEIGHT =2000GR - TO HAVE TESTED ON THE NEWBORN HEARING SCREENING UNIT AT ANKARA CITY HOSPITAL Exclusion Criteria: - PRETERMS - CRANIOFACIAL ANOMALIES - INTRAUTERINE INFECTIONS - BIRTH WEIGHT <2000 GR

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• hearing test
Auditory Brainstem Response (ABR) Test

Locations
Country Name City State
Turkey Fuat Emre Canpolat Ankara [Select]

Sponsors (1)
Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hearing Loss Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes 6 months
Secondary diabetic mother Evaluation of classification tests by separating them from subgroups according to mothers' control times, usage controls, and glycemic viewers 6 months
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