Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Closure of the Ductus
研究概览
简要总结
The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.
详细描述
Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Days 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus
排除标准
- •Major congenital anomalies
- •Life-threatening infection
- •Active NEC and/or intestinal perforation
- •Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
- •Urine output <1 ml per kilogram per hour during the preceding 8 hours
- •Serum creatinine concentration of >1.6 mg %
- •Platelet count of <60,000 per cc.
研究组 & 干预措施
Paracetamol
Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days
干预措施: Paracetamol (Drug)
NSAID
Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr
干预措施: NSAID (Drug)
NSAID
Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr
干预措施: D5W (Drug)
结局指标
主要结局
Closure of the Ductus
时间窗: 3 days
次要结局
- Absence of peripheral vasoconstriction(48 hours)
- Absence of hepatotoxicity(1 week)
研究者
Cathy Hammerman
Prof. Pediatrics
Shaare Zedek Medical Center