ACTRN12615000981527尚未招募4 期
In preterm infants with a haemodynamically significant ductus arteriosus, does oral paracetamol treatment compared to intravenous indomethacin result in greater narrowing or closure of the ductus arteriosus?
Monash Newborn, Monash Children's Hospital0 个研究点目标入组 150 人开始时间: 2015年9月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 7 Days 至 14 Days（—）
- 性别
- All
入选标准
- •Gestation: less than 32 weeks (up to 31 weeks 6 days) gestation
- •Post-natal (or post-gestation) age of greater than/equal to 7 days OR following the second routine cranial ultrasound assessment
- •Clinical suspicion of a haemodynamically significant PDA, e.g.
- •Active praecordium, loud murmur or wide pulse pressure
- •The need for respiratory support (defined as CPAP/NIMV/IMV/HFO) with FiO2 greater than or equal to 30%. These infants should have an echocardiographic assessment to confirm the presence of PDA
- •Echocardiographic evidence of either:
- •Significant left-to-right shunting across PDA (hsDA score of equal or greater than 6) comprising transductal diameter, velocity and left atrial aortic root ratio OR
- •A composite score of greater than or equal to than 16 based on the Sehgal score
- •Infant is on minimal enteral feed defined as less than or equal to 10ml/kg/day
排除标准
- •Major congenital abnormalities, including congenital heart disease
- •Severe intraventricular haemorrhage (IVH) (grade 3 or 4)
- •Evidence of coagulation dysfunction: Platelet count < 100,000/microlitre or presence of blood in endotracheal/gastric aspirate, haematuria
- •Intrauterine growth restriction defined as <3rd centile and/or reverse end diastolic flow on antenatal Dopplers.
- •Echocardiographic evidence of significant right-to-left shunting across PDA
- •Elevated serum creatinine > 100 micromol/L
- •Concerns about abdominal problems (feeding intolerance aspirates > feeding volume, bilious colour, abdominal distension)
- •Life threatening sepsis
- •Urine output of less than 1ml/kg/hour during the preceding 8 hours
- •Evidence of liver dysfunction or hyperbilirubinaemia requiring exchange transfusion
- •Decision not-to-treat by the attending neonatologist
研究者
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