Effect of Feedings on Caffeine in Premature Infants

• Status: Completed
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: University of North Carolina, Chapel Hill
• Treatments: Caffeine; Caffeine citrate

Criteria

Inclusion Criteria:

• Written informed consent from parent(s) or legal guardian(s)

• <29 weeks birth gestational age

• Postnatal age ≤15 days

• Receiving caffeine (intravenous or oral) per standard of care for prevention or treatment of apnea of prematurity

Exclusion Criteria:

• Known major congenital or chromosomal anomaly