Effect of Feedings on Caffeine in Premature Infants
Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
Participant gender:
Summary
Almost all infants born <29 weeks gestational age develop apnea of prematurity and are
treated with caffeine. Type of diet and disease states may be significant contributors of
variability in caffeine metabolism and pharmacokinetics (PK) in this population. This
prospective, observational, open-label, opportunistic PK study will compare the population PK
of caffeine between infants fed formula and infants fed exclusively breast milk; compare the
activities of caffeine metabolizing enzymes between infants fed formula and infants fed
exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on
caffeine PK and metabolism in premature infants.