Oral Caffeine Treatment Compared to Placebo for Newborns with Moderate to Severe Hypoxic Ischemic Encephalopathy

What this Trial Is About

This trial evaluates oral caffeine treatment compared to placebo in newborns diagnosed with moderate to severe hypoxic ischemic encephalopathy HIE, a brain injury caused by lack of oxygen around birth. The study aims to reduce death or serious neurodevelopmental problems by 18 to 22 months of age. HIE is usually treated with cooling therapy, but this study explores caffeine as a potentially beneficial and low-cost alternative. Newborns at least 36 weeks gestation and weighing 1800 grams or more, diagnosed within six hours after birth, are randomly assigned to receive either caffeine or placebo. The caffeine group receives one 20 mgkg dose followed by two 10 mgkg doses at 24-hour intervals by mouth or feeding tube. The placebo group receives identical doses without caffeine. Sub-studies include blood sampling for caffeine levels, brain imaging with MRI, and cord blood collection for molecular analysis. Participants undergo assessments during hospitalization and follow-up visits up to 18 to 22 months old. Researchers measure survival and neurodevelopmental outcomes using physical exams, developmental tests, neurological scales, growth measures, and kidney function tests. Safety is monitored closely, and serious adverse events are recorded. The total study duration extends until final outcome assessments at nearly two years of age.

Caffeine for Hypoxic Ischemic Encephalopathy