Effect of Feedings on Caffeine in Premature Infants

September 11, 2017 updated by: Duke University

Effect of Feedings on Caffeine Pharmacokinetics and Metabolism 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • North Carolina Children's Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Premature infants given caffeine for the prevention or treatment of apnea of prematurity.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premature infants
Premature infants <29 weeks birth gestational age receiving caffeine per standard of care for the prevention or treatment of apnea of prematurity.
Drug: Caffeine
Given per standard of care.
Other Names:
  • Cafcit
  • Caffeine Citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance (CL) of caffeine at steady state
Time Frame: Study days 0, 15, 30, 45, and 60.
Using population pharmacokinetic analyses
Study days 0, 15, 30, 45, and 60.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of distribution (V) of caffeine at steady state
Time Frame: Study days 0, 15, 30, 45, and 60
Using population pharmacokinetic analyses
Study days 0, 15, 30, 45, and 60
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
Study days 0, 15, 30, 45, and 60
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
Study days 0, 15, 30, 45, and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Phillip B Smith, MD, MPH, MHS, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00058253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will consider on a case-by-case basis (de-identified data only)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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