Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PDA Closure
研究概览
简要总结
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
详细描述
Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 29 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation
- •Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt
- •Signed informed consent
排除标准
- •Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,
- •Active bleeding (including Grade 3 or 4 IVH)
- •Platelet count < 100,000
- •Coagulopathy
- •Suspected NEC
- •Suspected perforation
- •Creatinine > 1.5
- •Hyperbilirubinemia requiring exchange transfusion
- •Hypotension requiring pressor support
- •Life-threatening congenital malformation
研究组 & 干预措施
Optimized Ibuprofen
干预措施: optimized ibuprofen (Drug)
Standard Ibuprofen
干预措施: Standard Ibuprofen (Drug)
结局指标
主要结局
PDA Closure
时间窗: 1-42 days of age
次要结局
- renal function(1-30 days of age)
研究者
James Hocker
M.D.
OSF Healthcare System