Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

Who is this study for? Patients with Congenital Heart Disease in Children
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life.

• Informed consent provided by both parents.

Locations
Other Locations
Netherlands
University Medical Center Groningen (UMCG)
RECRUITING
Groningen
Radboud University Medical Center Nijmegen (Radboudumc)
ACTIVE_NOT_RECRUITING
Nijmegen
Erasmus Medical Center Rotterdam (Erasmus MC)
RECRUITING
Rotterdam
University Medical Center Utrecht (UMC Utrecht)
RECRUITING
Utrecht
Contact Information
Primary
Manon JNL Benders, Prof. MD PhD
m.benders@umcutrecht.nl
0031887554545
Backup
Maaike Nijman, MD
m.nijman@umcutrecht.nl
Time Frame
Start Date: 2020-02-14
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 236
Treatments
Active_comparator: Allopurinol
Placebo_comparator: Placebo
Authors
W A Helbing, Sylke J Steggerda
Sponsors
Collaborators: University Medical Center Groningen, University Medical Center Nijmegen, ACE Pharmaceuticals BV, Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: dr. M.J.N.L. Benders

This content was sourced from clinicaltrials.gov