Diagnosis and treatment of postoperative delirium and withdrawal syndrome, detection of brain abnormalities and developmental neurological outcomes in children with complex congenital heart defects.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038949

Enrollment

300

Registered

2026-01-13

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Q20-Q28

Interventions

Group 1: The study includes newborns and infants with congenital heart defects who undergo heart surgery within the first year of life. Excluded are premature infants born before 36 weeks of gestatio

164:308-317). - Screening for withdrawal syndrome – study-related measure: Postoperative screening for withdrawal syndrome (Withdrawal Assessment Tool), known as the WAT-1 score (Chiu et al 2017). Fr

Eligibility

Sex/Gender

All

Age

1 Days to 1 Years

Inclusion criteria

Inclusion criteria: Newborns and infants with congenital heart defects who undergo heart surgery within their first year of life.

Exclusion criteria

Exclusion criteria: Premature infants born before 36 weeks of gestation.

Design outcomes

Primary

Measure	Time frame
- Diagnosis and treatment of postoperative delirium (mandatory) - Diagnosis and treatment of postoperative withdrawal syndrome (mandatory) - Detection of delayed brain maturation and brain pathologies (optional) - Developmental neurological outcome at 6–9, 12 and 24 months of age (mandatory)	—

Secondary

Measure	Time frame
- Recording of risk factors for impaired development (patient-specific clinical data, socio-economic status)	—

Countries

Germany

Contacts

Public ContactSylvia Schroth

Universitätsklinikum Bonn

sylvia.schroth@ukbonn.de+4922828737500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026