Clinical Trials Logo
  1. Home
  2. Hearing Loss
  3. NCT05152589
  4. Details
NCT05152589 Clinical Trial

Maternal Diabetes in Newborns With Hearing Loss

Hearing Loss Clinical Trial

— GDM  

Official title:
Newborn Hearing Loss

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05152589
Other study ID # E2-21-1070
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date June 30, 2023

Study information
Verified date November 2021
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Fuat Emre Canpolat Ankara [Select]

Sponsors (1)
Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hearing Loss Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes 6 months
Secondary diabetic mother Evaluation of classification tests by separating them from subgroups according to mothers' control times, usage controls, and glycemic viewers 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04696835 - fNIRS in Pediatric Hearing Aids N/A
Completed NCT03662256 - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine N/A
Completed NCT04602780 - Evaluating the Revised WORQ in CI Users
Completed NCT03723161 - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03428841 - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients N/A
Completed NCT04559282 - Home Test of New Sound Processor N/A
Enrolling by invitation NCT03345654 - Individually-guided Hearing Aid Fitting
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Completed NCT05165121 - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Terminated NCT02294812 - Effects of Cognitive Training on Speech Perception N/A
Completed NCT04622059 - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis N/A
Recruiting NCT02558478 - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing N/A
Withdrawn NCT02740322 - Validating the Hum Test N/A
Completed NCT01963104 - Community-Based Kiosks for Hearing Screening and Education N/A
Completed NCT01892007 - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users N/A
Completed NCT01857661 - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial N/A
Withdrawn NCT01223638 - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism N/A