The interplay between prenatal speech input and brain maturation in early language development

Recruiting

• Conditions: Taalontwikkeling, auditieve ontwikkeling; gestational diabetes; maternal diabetes

• Registration Number: NL-OMON54637
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

Experiments 1 and 2:
At-risk group:
- Born at >37 weeks.
- Consent signed by the parents/guardians at 30 weeks of gestation or within
24h after birth
- Mother diagnosed with gestational diabetes
Control group:
- Born at >37 weeks.
- Consent signed by the parents/guardians at 30 weeks of gestation or within 24
h after birth

Experiment 3:
Early preterm group:
- Born between 28-30 weeks
- Consent signed by the parents/guardians within 1 week after birth
- Normal birth weight for the postconceptional age

Late preterm group:
- Born between 31-33 weeks
- Consent signed by the parents/guardians within 1 week after birth
- Normal birth weight for the postconceptional age

Exclusion Criteria

Experiments 1 and 2:
- Suspected or proved genetic neural disorders
- Congenital malformations
- Severe perinatal complications
- No consent from the parents/guardians
- Bilingual home (< 70% exposure to Dutch)
- Deaf mothers
- Mother diagnosed with a different type of diabetes

In addition, subjects will be withdrawn from the study if:
- Born pre-term (<37 weeks of gestation)
- Impaired hearing abilities
- Withdrawn parental/guardian consent
- Unacceptable adverse events

Experiment 3:
- Suspected or proved genetic neural disorders
- Congenital malformations
- Severe perinatal complications
- No consent from the parents/guardians
- Bilingual home (< 70% exposure to Dutch)

In addition, subjects will be withdrawn from the study if:
- Mother diagnosed with (gestational) diabetes
- Impaired hearing
- Withdrawn parental/guardian consent
- Unacceptable adverse events

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>EEG event-related potentials indicating maturation of general auditory<br /><br>perception and speech-specific perception </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N.A.</p><br>