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Clinical Trials/NCT05152589
NCT05152589
Unknown
Not Applicable

Newborn Hearing Loss

Ankara City Hospital Bilkent1 site in 1 country500 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Ankara City Hospital Bilkent
Enrollment
500
Locations
1
Primary Endpoint
Hearing Loss
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 30, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • CRANIOFACIAL ANOMALIES
  • INTRAUTERINE INFECTIONS
  • BIRTH WEIGHT \<2000 GR

Outcomes

Primary Outcomes

Hearing Loss

Time Frame: 6 months

Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes

Secondary Outcomes

  • diabetic mother(6 months)

Study Sites (1)

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