Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic Mothers

NCT ID: NCT04845412

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-06-01

Brief Summary

In this study, the investigators have aimed to investigate whether GDM is a risk factor for hearing impairment in newborns. To the investigators knowledge, this study is the first prospective, controlled study on this subject.

Detailed Description

Gestational diabetes mellitus (GDM) is an increasingly frequent condition in the world causing significant morbidity and mortality. GDM is a metabolic disease that develops in pregnancy, and may result in complications in the pregnant women, similar to other patients with diabetes. The prevalence of GDM varies in relation with the population and the diagnostic criteria. Diabetes affects 6-9% of pregnant women; 99% of the cases have GDM, and diabetes is diagnosed before pregnancy in the remaining 1% [(pre-gestational diabetes mellitus (pre-GDM)]. Hearing loss is one of the most common birth defect in newborns. The incidence of congenital hearing impairment is 2-3 per 1000 births. Early diagnosis and treatment is very important for the development of auditory pathways and protection of cognitive functions. Therefore, newborn hearing screening programs have been in use in a number of countries. Transient evoked otoacoustic emissions (TEOAE) and auditory brainstem response (ABR) have been identified as basic convenient and applicable tools for neonatal screening of hearing.

Suboptimal glycemic control during pregnancy has adverse fetal effects. Congenital malformations, preterm birth and neonatal respiratory distress in the newborn are more common, at varying rates, pre-GDM and GDM. Compared to the normal population, the risk of congenital malformations is 1.9-10 fold higher in presence of pre-GDM, and 1.1-1.3 fold higher in presence of GDM. Despite our awareness on these important complications, the effect of intrauterine hyperglycemia on hearing of the newborn has not yet been studied in detail. Diabetes mellitus (DM) often causes hearing impairment, however little is known whether GDM is an antenatal risk factor for cochlear damage and hearing loss.

Conditions

Gestational Diabetes; Hearing Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children of GDM parents

Children of mothers who have gestational diabetes mellitus

Hearing screening tests

Intervention Type: DIAGNOSTIC_TEST

Our study was conducted in accordance with the National Hearing Screening Test Protocol. The newborns had transient evoked otoacoustic emissions (TEOAE) with "click" stimulus as a hearing screening test in the first three days after birth, using Otometrics Madsen Accuscreen S/N: 36484 (USA) device.

Children of non-diabetic parents

Children of mothers without diabetes

Hearing screening tests

Intervention Type: DIAGNOSTIC_TEST

Our study was conducted in accordance with the National Hearing Screening Test Protocol. The newborns had transient evoked otoacoustic emissions (TEOAE) with "click" stimulus as a hearing screening test in the first three days after birth, using Otometrics Madsen Accuscreen S/N: 36484 (USA) device.

Interventions

Hearing screening tests

Our study was conducted in accordance with the National Hearing Screening Test Protocol. The newborns had transient evoked otoacoustic emissions (TEOAE) with "click" stimulus as a hearing screening test in the first three days after birth, using Otometrics Madsen Accuscreen S/N: 36484 (USA) device.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women with gestational diabetes
• Women without diabetic pregnancy

Exclusion Criteria

• Admitted to the neonatal intensive care unit for more than five days
• Perinatal asphyxia
• Craniofacial abnormalities
• İntrauterine infections
• Hyperbilirubinemia requiring exchange transfusion
• Very low birth weight (<1500 g)
• Gestational hypertension
• Preeclampsia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Esra Gulen Yıldız

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra Gulen Yildiz

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Resarch Hospital

Locations

Ankara Training and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CGDMP2020

Identifier Type: -

Identifier Source: org_study_id