NCT02002741已完成2 期
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The incidence of patent ductus arteriosus closure
研究概览
简要总结
The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
详细描述
Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at 24-37 gestational age
- •diagnosis of Hemodynamically significant patent ductus arteriosus
- •Medical staff decided to treat with Ibuprofen
- •Parents have signed informed consent
排除标准
- •Contraindication for ibuprofen
- •Alanine transaminase /Aspartate transaminase≥ 200 U/L
- •Significant congenital heart disease
研究组 & 干预措施
Ibuprofen + Paracetamol
Active Comparator
Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses
- Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses
干预措施: Paracetamol (Drug)
Ibuprofen + Placebo
Placebo Comparator
Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses
- Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of patent ductus arteriosus closure
时间窗: 3-10 days after first dose of Ibuprofen + study drug
By echocardiography
次要结局
- Adverse effects(until discharge home (usually within 2-3 months since recruitment))
- The need for surgical ligation for PDA(3-21 days after first dose of Ibuprofen + study drug)
研究者
研究点 (1)
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