BridgeMD
Effect of ALlopurinol in addition to hypothermia for hypoxicischemic Brain Injury on Neurocognitive Outcome
EU CTIS ID: 2024-511322-31-00
What this study is testing
To evaluate whether in newborns with asphyxia and early clinical signs of hypoxic ischemic encephalopathy, early postnatal allopurinol compared to placebo administered in addition to standard of care (including therapeutic hypothermia if indicated) reduces the incidence of death or severe neurodevelopmental impairment (defined as cerebral palsy, or cognitive or language impairment, the latter defined as cognitive- and the language-composite scores of the Bayley Scales of Infant and Toddler Development (3rd edition) <85) at 24 months of age.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Severe perinatal metabolic acidosis or ongoing cardiopulmonary resuscitation at 5 min after birth
- Early clinical signs of potentially evolving encephalopathy
You likely can't join if
- gestational age below 36 weeks
- birth weight below 2500 g
- postnatal age >30min at the end of screening phase
- severe congenital malformation or syndrome requiring neonatal surgery or affecting long-term outcome
- patient considered “moribund” / “non-viable” (e.g., lack of spontaneous cardiac activity and ongoing chest compression at 30min)
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.