Maternal Diabetes in Newborns With Hearing Loss (GDM)

November 29, 2021 updated by: Ankara City Hospital Bilkent

Newborn Hearing Loss

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • [Select]
      • Ankara, [Select], Turkey, 06800
        • Fuat Emre Canpolat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NEWBORNS WHO CANNOT PASS THE HEARING TEST APPLIED AS ROUTINE SCREENING

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Loss
Time Frame: 6 months
Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diabetic mother
Time Frame: 6 months
Evaluation of classification tests by separating them from subgroups according to mothers' control times, usage controls, and glycemic viewers
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (ACTUAL)

December 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-21-1070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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