The primary objective of the study is to characterize safety, efficacy and exposure-response relationship of caffeine citrate. The study included the retrospective analysis of clinical data for premature infants who received caffeine citrate per standard of care (SOC), gathered from three sources. Caffeine citrate used at greater doses for longer durations in more immature (e.g., lower Gestational Age) infants than the FDA label appears to be a safe therapy for the treatment of Apnea of Prematurity. Caffeine citrate use is not associated with an increased risk for Necrotizing Enterocolitis.”
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