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Effect of Feedings on Caffeine in Premature Infants

NCT02293824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-09-13

No results posted yet for this study

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.

Conditions

  • Apnea of Prematurity
  • Premature Newborn
  • Caffeine

Interventions

DRUG

Caffeine

Given per standard of care.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Phillip B Smith, MD, MPH, MHS · Duke Clinical Research Institute

Eligibility

Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293824 on ClinicalTrials.gov