Melatonin for newborns with brain injury after oxygen problems
Treatments studied
Part of Brain & nervous system, Heart & circulation clinical trials.
This early study tests whether giving melatonin to newborns with hypoxic-ischemic encephalopathy (brain injury from not enough oxygen around birth) can help protect the brain while they are cooled (therapeutic hypothermia). It may be most relevant if your baby shows early brain-injury signs and meets specific blood test and birth-history timing criteria.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Baby was born after 36 weeks of pregnancy (more than 36 0/7 weeks).
- Blood test shows signs of severe acid stress: pH below 7.0 and base deficit above 16 mEq/L, or (if using another blood gas window) a pH between 7.0 and 7.15 with a base deficit between 10 and 15.9 mEq/L.
- A serious “acute event” happened around birth, and the baby either had a 10-minute Apgar score under 5 or still needs help breathing/ventilation.
- The baby shows signs of brain injury within 6 hours after birth, based on an exam scoring system doctors use.
- Cooling therapy (therapeutic hypothermia) started within 6 hours of birth.
- Doctors did a sepsis evaluation, and there is no evidence of meningitis on that workup.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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