Maternal Diabetes in Newborns With Hearing Loss

NCT05152589 | Unknown

• 1 other identifier: E2-21-1070
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Pregestational Diabetes; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Hearing Loss

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

  6 months

Secondary Outcomes (1)

• diabetic mother

  6 months

Study Arms (3)

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

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

non diabetic mother

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

Diagnostic Test: hearing test

Interventions

hearing test DIAGNOSTIC_TEST

Auditory Brainstem Response (ABR) Test

Also known as: ABR

gestational diabetic mother; non diabetic mother; pregestational diabetic mother

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

NEWBORNS WHO CANNOT PASS THE HEARING TEST APPLIED AS ROUTINE SCREENING

You may qualify if:

• POSTNATAL AGE BETWEEN 0-28 DAYS
• BIRTH WEIGHT ≥2000GR
• TO HAVE TESTED ON THE NEWBORN HEARING SCREENING UNIT AT ANKARA CITY HOSPITAL

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Fuat Emre Canpolat

Ankara, [Select], 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hearing Loss

Interventions

Hearing Tests

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)