ICAF protocol
The ICAF Study is an NIH-funded multicenter randomized controlled trial in infants born preterm (NCT03321734), in which convalescent preterm infants treated with caffeine are randomized to continued caffeine or placebo at the time of clinical caffeine discontinuation. The primary aims of the study are to compare, from randomization through 42Beginning at enrollment at 32The study protocol continues at home for several weeks, the duration depending on PMA at NICU discharge. Twice daily administration of the enteral study drug is continued at home until 42The target sample size is 220 subjects, including at least 200 with complete data for analysis. Based on prior experience, we estimated that 40% of all infants born at ≤ 30