CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 target
Drug / intervention
Caffeinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02293824
NCT02293824N/ACompleted
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Effect of Feedings on Caffeine Pharmacokinetics and Metabolism in Premature Infants

Duke University·observational·Posted Nov 18, 2014·Updated Sep 13, 2017

In Brief

An observational study evaluating Caffeine for Apnea of Prematurity and 2 related conditions. Completed, enrolled 50 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsApnea of Prematurity, Premature Newborn, Caffeine
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 18, 2014
Enrollment StartDec 1, 2014
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.6 years ago

Interventions

Caffeinedrug

Given per standard of care.