Long-term Early Development Research in Children with Hypoplastic Left Heart Syndrome

Long-term Early Development Research in Children with Hypoplastic Left Heart Syndrome - LEADER-HLHS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016414

Enrollment

Registered

2019-01-09

Start date

2019-01-10

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

Q23.4

Interventions

Group 1: Infants with HLHS undergoing treatment at the German Heart Center Berlin. We will administer the Bayley III Scale of Infant development at ages 12 months, 24 months and 36 months in order to

Eligibility

Sex/Gender

All

Age

0 Months to 11 Months

Inclusion criteria

Inclusion criteria: - At least 1 parent with sufficient German language proficiency - child is diagnosed with hypoplastic left heart syndrome

Exclusion criteria

Exclusion criteria: Known drug-/alcohol abuse/dependence in history of the mother

Design outcomes

Primary

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

Secondary

Measure	Time 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

Deutsches Herzzentrum Berlin Klinik für angeborene Herzfehler - Kinderkardiologie

olsson@dhzb.de03045932808

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026