Metabolism and Toxicity of Acetaminophen in Preterm Infants
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- primary endpoint PK analysis
研究概览
简要总结
The purpose of this study is to investigate how acetaminophen (APAP) is released into the urine and blood; to determine how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; to decrease adverse drug reactions; and to collect data on how the genetic make-up or characteristics affect how APAP is handled within the preterm infant. By taking several blood and urine samples during the study, we will be able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.
详细描述
Study procedures: The decision to replace standard intravenous morphine therapy with APAP will be made by the attending neonatologist.
Length of participation: 60 hours. No patient will be prescribed the medication specifically for the study purposes in the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm and term neonates of both genders and all races
- •a postnatal age of less than 28 days
- •GA's of from 22 to less than 37 weeks
- •an indwelling (peripheral or umbilical) arterial line
- •a clinical indication for intravenous administration of pain relief medication
排除标准
- •Neonates with severe asphyxia
- •grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations (e.g., cleft lip and palate),
- •neurological disorders
- •those receiving continuous or intermittent neuromuscular blockers
- •clinical or biochemical evidence of hepatic renal failure (including systemic hypoperfusion)
研究组 & 干预措施
group 2 Pain management
In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute.
In preterm and term neonates with a GA of less than 28 weeks 15 mg/kg dose of APAP will be given every 12 hrs by an intravenous infusion over 30-minute
干预措施: Acetaminophen/APAP (Drug)
结局指标
主要结局
primary endpoint PK analysis
时间窗: 48 hours
Blood and urine levels of APAP and metabolites
次要结局
- Developmental stage(48 hours)
研究者
John van den Anker
MD
Children's National Research Institute