Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00011006
Enrollment
180
Registered
2016-11-18
Start date
2017-01-16
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q21.0 Q20.3 Q21.3

Interventions

Group 1: Children who undergo correction surgery for a ventricular septal defect before the age of 10 months. We will administer the Bayley III Scale of Infant development at ages 12 months, 24 months

Sponsors

Klinik für Angeborene Herzfehler - Kinderkardiologie, Deutsches Herzzentrum Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Months to 10 Months

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactAnke Olsson

Klinik für angeborene Herzfehler - Kinderkardiologie, Deutsches Herzzentrum Berlin

olsson@dhzb.de03045932808

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 25, 2026