Maternal Diabetes in Newborns With Hearing Loss

• Conditions: Hearing Loss; Gestational Diabetes; Pregestational Diabetes
• Interventions: Diagnostic Test: hearing test

• Registration Number: NCT05152589
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Study First Posted: 2021-12-10
• Last Update Posted: 2021-12-10
• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non diabetic mother	hearing test	Hearing tests of babies whose mothers do not have gestational or pregestational diabetes
gestational diabetic mother	hearing test	Hearing tests of the babies of pregnant women who are being followed up with the diagnosis of gestational diabetes in the peritanotogy clinic
pregestational diabetic mother	hearing test	Hearing tests of the babies of pregnant women who are being followed up with the diagnosis of pregestational diabetes in the peritanotogy clinic

Primary Outcome Measures

Name	Time	Method
Hearing Loss	6 months	Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes

Secondary Outcome Measures

Name	Time	Method
diabetic mother	6 months	Evaluation of classification tests by separating them from subgroups according to mothers' control times, usage controls, and glycemic viewers

Trial Locations

Locations (1)

Fuat Emre Canpolat; 🇹🇷 Ankara, [Select], Turkey