Patent Ductus Arteriosus in preterm infants treated by oral paracetamol versus intravenous ibuprofen and ductal closure.

Monash Newborn0 个研究点目标入组 60 人开始时间: 2014年7月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Gestation: < 30 weeks completed gestation
•Post-natal age of greater than or equal to 7 days OR following the second routine cranial ultrasound assessment
•Clinical suspicion of a haemodynamically significant PDA
•Active praecordium, loud murmur or wide pulse pressure
•The need for respiratory support (defined as CPAP/NIMV/IMV/HFO) with FiO2 of 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 of greater than or equal to 6) comprising transductal diameter, velocity and left atrial aortic root ratio (10) OR
•A composite score of of greater than or equal to 16 based on our earlier publication
•Infant is on minimal enteral feed defined as of greater than or equal to 10ml/kg/day

•Major congenital abnormalities
•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

发起方

Monash Newborn