Using Allopurinol to Improve Outcomes in Infants with Brain Injury from Lack of Oxygen
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)
This study is testing if giving a medication called allopurinol right after birth can help improve brain function in babies who have suffered brain injury due to a lack of oxygen.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 760 (estimated) |
| Ages | N/A to 45 Minutes |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 12 sites (Wien and 11 other locations) |
| Trial ID | NCT03162653 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of allopurinol, a xanthine oxidase inhibitor, administered immediately after birth to near-term infants suffering from hypoxic-ischemic encephalopathy (HIE) in conjunction with hypothermic treatment. HIE is a significant cause of long-term disability in newborns, and current treatments have not sufficiently improved outcomes. The study aims to determine if adding allopurinol can further reduce brain damage and improve neurocognitive outcomes in affected infants. The trial involves monitoring infants for clinical signs of encephalopathy and assessing their neurodevelopmental progress over time.
Who should consider this trial
Good fit: Ideal candidates for this study are term and near-term infants who have experienced perinatal asphyxia and show clinical signs of evolving encephalopathy.
Not a fit: Patients who do not meet the criteria for perinatal acidosis or those without signs of encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of long-term neurodevelopmental impairments in infants affected by hypoxic-ischemic encephalopathy.
How similar studies have performed: Previous studies have shown promising results with similar neuroprotective approaches, but the use of allopurinol in this specific context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Term and near-term infants with a history of disturbed labour who meet at least one criterion of perinatal acidosis (or ongoing resuscitation) and at least two early clinical signs of potentially evolving encephalopathy as defined herein: Severe perinatal metabolic acidosis or ongoing cardiopulmonary resuscitation at 5 min after birth: At least 1 out of the following 5 criteria must be met * Umbilical (or arterial or reliable venous) blood gas within 30 min after birth with pH\<7.0 * Umbilical (or arterial or reliable venous) blood gas within 30 min after birth with base deficit ≥16 mmol/l * Need for ongoing cardiac massage at/beyond 5 min postnatally * Need for adrenalin administration during resuscitation * APGAR score ≤5 at 10min AND Early clinical signs of potentially evolving encephalopathy: At least 2 out of the following 4 criteria must be met: * Altered state of consciousness (reduced or absent response to stimulation or hyperexcitability) * Severe muscular hypotonia or hypertonia, * Absent or insufficient spontaneous respiration (e.g., gasping only) with need for respiratory support at 10 min postnatally * Abnormal primitive reflexes (absent suck or gag or corneal or Moro reflex) or abnormal movements (e.g., potential clinical correlates of seizure activity) Exclusion criteria * 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) * decision for "comfort care only" before study drug administration * parents declined study participation as response to measures of community engagement * both parents are insufficiently fluent in the study site's national language(s) or English or do not seem to have the intellectual capacity to understand the study procedures and to give consent as judged by the personnel who had been in contact with the mother/father before delivery. * both parents/guardians less than 18 years of age, in case of single parent/guardian this one less than 18 years of age
Where this trial is running
Wien and 11 other locations
- Medizinische Universitaet Wien — Wien, Austria (Recruiting)
- Katholieke Universiteit Leuven — Leuven, Belgium (Recruiting)
- Tartu Ulikool — Tartu, Estonia (Recruiting)
- Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä — Helsinki, Finland (Recruiting)
- University Hospital Tübingen — Tübingen, Germany (Recruiting)
- Universita Degli Studi Di Udine — Udine, Italy (Recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Recruiting)
- Oslo Universitetssykehus Hf — Oslo, Norway (Recruiting)
- Uniwersytet Medyczny Im Karola Marcinkowskiego W Poznaniu — Poznań, Poland (Withdrawn)
- Universidade Do Porto — Porto, Portugal (Withdrawn)
- Para La Investigacion Del Hospital UniversitarioLa Fe De La Comunidad Valenciana — Valencia, Spain (Recruiting)
- Universitaet Zuerich — Zuerich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Rüdiger Mario, Prof. Dr. — University Children's Hospital Dresden
- Study coordinator: Oldershausen Gabriele
- Email: Albino@med.uni-tuebingen.de
- Phone: +49 7071 29-86176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.