EADER (Long-term Early Development Research) - A Study on the Development of Children with Congenital Heart Defects

Recruiting

• Conditions: Q21.0; Ventricular septal defect; Q20.3; Q21.3; Discordant ventriculoarterial connection; Tetralogy of Fallot

• Registration Number: DRKS00011006
• Lead Sponsor: Klinik für Angeborene Herzfehler - Kinderkardiologie, Deutsches Herzzentrum Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

One parent is german native speaker or both parents are german native speakers.

Exclusion Criteria

Genetic syndromes (except for microdeletionsyndrome 22Q11) or phenotypic anomalies that might influence the cognitive/motoric development (e.g., trisomy 21, 22Q deletion spectrum).
Birth weight under 2.5 kg.
Gestational Age of less than 37 weeks.
History of drug-/ alcoholabuse/ -dependence of the mother.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The motoric, cognitive and language development as measured with the Bayley III Scale at the ages of 12, 24, 36 months.

Secondary Outcome Measures

Name	Time	Method
Mortality (time of death derived from patient files). Child temperament as measured with the IBQ-R-SV (Infant Behavior Questionnaire-Revised, Short Version) at the age of 12 months.