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GDM: Maternal Diabetes in Newborns With Hearing Loss

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05152589
Collaborator
(none)
500
Enrollment
1
Location
17.9
Anticipated Duration (Months)
27.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: hearing test

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Newborn Hearing Loss
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
gestational diabetic mother

Hearing tests of the babies of pregnant women who are being followed up with the diagnosis of gestational diabetes in the peritanotogy clinic

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

    		•
    pregestational diabetic mother

    Hearing tests of the babies of pregnant women who are being followed up with the diagnosis of pregestational diabetes in the peritanotogy clinic

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

    		•
    non diabetic mother

    Hearing tests of babies whose mothers do not have gestational or pregestational diabetes

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hearing Loss [6 months]

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

    Secondary Outcome Measures

    1. diabetic mother [6 months]

      Evaluation of classification tests by separating them from subgroups according to mothers' control times, usage controls, and glycemic viewers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuat Emre Canpolat Ankara [Select] Turkey 06800

    Sponsors and Collaborators

    • Ankara City Hospital Bilkent

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ankara City Hospital Bilkent
    ClinicalTrials.gov Identifier:
    NCT05152589
    Other Study ID Numbers:
    • E2-21-1070
    First Posted:
    Dec 10, 2021
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness
    Diabetes, Gestational
    Diabetes Mellitus

    Study Results

    No Results Posted as of Dec 10, 2021