Effect of Feedings on Caffeine in Premature Infants
Completed
Conditions studied: Apnea of Prematurity, Premature Newborn, Caffeine
In brief
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.
Key facts
- Study ID
- NCT02293824
- Run by
- Duke University
- People needed
- 50
- Starts
- 2014-12-01
- Expected to finish
- 2017-06-30
- Last updated by the study team
- 2017-09-13
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Known major congenital or chromosomal anomaly
Where it is running
- North Carolina Children's Hospital — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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