Effect of Feedings on Caffeine Pharmacokinetics and Metabolism in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clearance (CL) of caffeine at steady state
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 15 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known major congenital or chromosomal anomaly
研究组 & 干预措施
Premature infants
Premature infants <29 weeks birth gestational age receiving caffeine per standard of care for the prevention or treatment of apnea of prematurity.
干预措施: Caffeine (Drug)
结局指标
主要结局
Clearance (CL) of caffeine at steady state
时间窗: Study days 0, 15, 30, 45, and 60.
Using population pharmacokinetic analyses
次要结局
- 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)