ACTRN12615000981527
Not yet recruiting
Phase 4
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 sites150 target enrollmentSeptember 21, 2015
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- Monash Newborn, Monash Children's Hospital
- Enrollment
- 150
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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