Plain-English translation of NCT02621944 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This early-stage trial is testing , a natural substance the body produces, to see if it can protect newborn brains after a serious birth complication called hypoxic ischemic encephalopathy (when babies don't get enough oxygen at birth). Babies enrolled will receive cooling therapy as standard treatment, and the study will see if adding this medication helps protect brain tissue and reduce injury. Researchers will carefully watch for safety and measure how well the babies develop over time.
Babies who don't get enough oxygen during birth can suffer serious brain damage that affects their development and quality of life. While cooling therapy helps, doctors are looking for additional treatments that might offer extra brain protection during this critical time.
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Your baby will receive the medication as an oral dose within the first 6 hours of life while undergoing standard cooling therapy. Depending on which group your baby is enrolled in, the medication may be given once or multiple times, at different dose levels. Your baby will have brain imaging (MRI), neurological exams, blood tests to check safety, and follow-up developmental assessments at 18–22 months of age to see how the treatment affected long-term development.
AI-generated summary from trial data · Aug 29, 2026 · Not medical advice
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