The effect of allopurinol on the reduction of brain injury in neonates with severe congenital heart disease

Phase 1

• Conditions: Brain injury in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.; MedDRA version: 20.0Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000004850; MedDRA version: 20.0Level: PTClassification code 10067967Term: Brain injurySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-004596-31-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 (anticipated) cardiac surgery with cardiopulmonary bypass (within the first 4 weeks of life).

Are the trial subjects under 18? yes
Number of subjects for this age range: 236
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. - 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 clinical trial of medicinal product
• Study Design: Not specified