CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass

Phase 3

Recruiting

• Conditions: Brain injury; 10010394; 10007510; 10010335

• Registration Number: NL-OMON52736
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 236

Inclusion Criteria

Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring
(anticipated) cardiac surgery with CBP within the first 4 weeks of life are
eligible for inclusion. This includes neonates with the following cardiac
defects 1) Transposition of the great arteries with or without a ventricular
septal defect undergoing arterial switch operation with ventricular septal
defect closure if needed; 2) Univentricular hearts: hypoplastic left and right
heart syndrome, or variant undergoing Norwood Stage I or Sano palliation; 3)
Aortic arch anomalies: interrupted, hypoplastic aortic arch and/or coarctation
of the aorta with or without intracardiac defects (ventricular/atrial septal
defect, or (sub)aortic stenosis) who undergo complete biventricular repair
and/or aortic arch repair; 4) Other variants: truncus arteriosus, total
anomalous pulmonary venous connection, or tetralogy of Fallot. Written informed
consent of both parents is required prior to inclusion.

Exclusion Criteria

- Inability to enroll the patient before the start of delivery in case of
prenatal diagnosis, or 24 hours before surgery in case of 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.
- Surgery not requiring cardiopulmonary
bypass.

- Patient considered
*moribund*.

- Decision for *comfort care only*.

Study & Design

• Study Type: Interventional
• Study Design: Not specified