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OpenTrials
Completed

NCT Number: NCT02293824

Effect of Feedings on Caffeine in Premature Infants

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.

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Key information

Conditions

Apnea of Prematurity Apnea Caffeine Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Premature Newborn Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

Up to 15 day

Sex eligibility

All sexes

Study type

Observational

Primary location

North Carolina Children's Hospital, Chapel Hill, North Carolina, United States

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About this study

This study will use a consecutive patient sampling approach. All eligible participants admitted at each site will be approached. Caffeine and feedings will be administered per standard of care. Manipulations of caffeine dosing or feeding regimens will not be a part of this protocol. To minimize the amount of blood sampling, the investigators will use a sparse sampling methodology. Urine will be collected for analysis of caffeine and caffeine metabolite concentrations. Caffeine pharmacokinetics will be described by population pharmacokinetic analysis. Urinary concentrations of caffeine and its metabolites will be used to calculate metabolic ratios as markers of enzyme activity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

Given per standard of care.

Other names: Caffeine Citrate, Cafcit

Primary outcomes

  1. Clearance (CL) of caffeine at steady state

    Time frame: Study days 0, 15, 30, 45, and 60.

    Using population pharmacokinetic analyses

Secondary outcomes

  1. Volume of distribution (V) of caffeine at steady state

    Time frame: Study days 0, 15, 30, 45, and 60

    Using population pharmacokinetic analyses

  2. Caffeine metabolizing enzyme activity using urinary metabolic ratios

    Time frame: Study days 0, 15, 30, 45, and 60

    Activity levels of CYP1A2, xanthine oxidase, and N-acetyltransferase 2

  3. Fold change in caffeine clearance due to hypoxia, hypotension, and infections

    Time frame: Study days 0, 15, 30, 45, and 60

    Effect of hypoxia, hypotension, and infections on caffeine clearance

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

Effect of Feedings on Caffeine Pharmacokinetics and Metabolism in Premature Infants

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2014
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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