A phase I trial of caffeine to evaluate safety in infants with hypoxic-ischemic encephalopathy.
Journal of perinatology : official journal of the California Perinatal Association(2023)
摘要
OBJECTIVE:Caffeine provides neuroprotection following hypoxic-ischemic injury in animals. We characterized the safety of escalating doses of caffeine in infants with hypoxic-ischemic encephalopathy (HIE) receiving therapeutic hypothermia.
STUDY DESIGN:Phase I trial of infants undergoing therapeutic hypothermia for HIE receiving IV caffeine 20 mg/kg followed by up to two daily doses of 5 mg/kg (n = 9) or 10 mg/kg (n = 8). Safety was evaluated based on adverse events and frequency of pre-specified outcomes compared to data from the Whole-Body Hypothermia for HIE trial (Shankaran, 2005).
RESULTS:Twelve of 17 (71%) infants had ≥1 adverse event during the study period. The frequency of clinical outcomes related to HIE were not statistically different from outcomes in infants receiving hypothermia in the Whole-Body Hypothermia for HIE trial.
CONCLUSION:Caffeine administration was well tolerated. A larger study is required to determine the optimal dose and evaluate drug safety and efficacy.
CLINICAL TRIAL:ClinicalTrials.gov Identifier: NCT03913221.
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