CeRebrUm and CardIac protection with ALlopurinol in Neonates with Critical Congenital Heart Disease requiring Cardiac Surgery with Cardiopulmonary Bypass

Phase 1

• Conditions: Brain injury in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.; MedDRA version: 21.1Level: PTClassification code: 10067967Term: Brain injury Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code: 10010495Term: Congenital heart disease NOS Class: 10010331; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2024-513041-37-00
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

Neonates with a prenatally (before birth) or postnatally (after birth) confirmed diagnosis of critical congenital heart disease requiring neonatal cardiac surgery with cardiopulmonary bypass within the first 4 weeks of life

Exclusion Criteria

Inability to enroll the patient before the start of delivery, in case of prenatal diagnosis or 24h before surgery in case op postnatal diagnosis., Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period., Gestational age below 36 weeks and /or birth weight less than 2000 gram., Patient considered moribund., Decision for comfort care only, Surgery not requiring cardiopulmonary bypass.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified