Maternal Diabetes in Newborns With Hearing Loss

Newborn Hearing Loss

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05152589

Acronym

GDM

Enrollment

500

Registered

2021-12-10

Start date

2022-01-01

Completion date

2023-06-30

Last updated

2021-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Pregestational Diabetes, Hearing Loss

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.

Interventions

DIAGNOSTIC_TESThearing test

Auditory Brainstem Response (ABR) Test

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

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

Design outcomes

Primary

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

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026