Effect of Feedings on Caffeine Pharmacokinetics and Metabolism in Premature Infants

Effect of Feedings on Caffeine in Premature Infants

Sponsors

Lead sponsor: Duke University

Collaborator: University of North Carolina, Chapel Hill

Source Duke University
Brief 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.

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.

Overall Status Completed
Start Date December 2014
Completion Date June 30, 2017
Primary Completion Date June 30, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Clearance (CL) of caffeine at steady state Study days 0, 15, 30, 45, and 60.
Secondary Outcome
Measure Time Frame
Volume of distribution (V) of caffeine at steady state Study days 0, 15, 30, 45, and 60
Caffeine metabolizing enzyme activity using urinary metabolic ratios Study days 0, 15, 30, 45, and 60
Fold change in caffeine clearance due to hypoxia, hypotension, and infections Study days 0, 15, 30, 45, and 60
Enrollment 50
Condition
Intervention

Intervention type: Drug

Intervention name: Caffeine

Description: Given per standard of care.

Arm group label: Premature infants

Eligibility

Sampling method: Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 15 Days

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Phillip B Smith, MD, MPH, MHS Principal Investigator Duke Clinical Research Institute
Location
facility
North Carolina Children's Hospital | Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center | Durham, North Carolina, 27710, United States
Location Countries

United States

Verification Date

June 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Premature infants

Description: Premature infants <29 weeks birth gestational age receiving caffeine per standard of care for the prevention or treatment of apnea of prematurity.

Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov