Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a blinded randomized placebo controlled parallel group multicenter trial for superiority (Phase III)
Phase 3
Recruiting
- Conditions
- 10028920brain damageencephalopathy10010335
- Registration Number
- NL-OMON54639
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Term and near-term infants with perinatal asphyxia and encephalopathy as
defined herein.
Exclusion Criteria
- Gestational age below 36 weeks - Birth weight below 2500 g - Postnatal age
>30minutes at the end of the screening phase, - Severe congenital
malformation or syndrome requiring neonatal surgery or affecting long-term
outcome - Patient considered *moribund* / *non-viable* - Decision for *comfort
care only* before study drug administration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Death<br /><br>2. Severe neurodevelopmental impairment at the age of two years </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Brain injury assessed by magnetic resonance imaging.<br /><br>2. Amplitude integrated electroencephalogram and full scale<br /><br>electroencephalogram.<br /><br>3. Brain injury at cerebral ultrasound.<br /><br>4. Laboratory biomarkers and markers of peroxidation.<br /><br>5. Safety of allopurinol in neonates treated with hypothermia.<br /><br>6. The pharmacokinetics of allopurinol in neonates treated with hypothermia and<br /><br>not treated with hypothermia<br /><br>7. Multi-organ dysfunction before discharge<br /><br>8. Echocardiography</p><br>