Effect of Feedings on Caffeine in Premature Infants
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/29/2017 |
| Start Date: | December 2014 |
| End Date: | June 30, 2017 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
Principal Investigator: Matthew Laughon, MD, MPH
Phone: 919-966-5063
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Phillip B Smith, MD, MPH, MHS
Phone: 919-681-6024
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