None listed
Conditions
Brief summary
This will be a placebo randomised control trial conducted in the neonatal intensive care unit. The trial will compare oral paracetamol against current standard therapy for a haemodynamically significant ductus arteriosus, which is intravenous indomethacin.
Interventions
Paracetamol, delivered orally
Dosage: 15 mg/kg 6 hourly for 3 days, per course of treatment.
The assessment for ductal status after the first course will be made by the neonatologist responsible for the infant who will base decision-making based on the echocardiography performed after the first course of treatment (within 72 hours after first treatment). The neonatologist will then decide if a second course of treatment is required (with input from paediatric cardiology).
The second course of t
Paracetamol, delivered orally Dosage: 15 mg/kg 6 hourly for 3 days, per course of treatment. The assessment for ductal status after the first course will be made by the neonatologist responsible for the infant who will base decision-making based on the echocardiography performed after the first course of treatment (within 72 hours after first treatment). The neonatologist will then decide if a second course of treatment is required (with input from paediatric cardiology). The second course of treatment will be given if on the second echocardiography (within 72 hours after first treatment) shows the presence of a hemodynamically significant ductus arteriosus and if the attending neonatologist decides. The maximum number of treatment courses will be two. Infant randomised to oral paracetamol arm will receive intravenous placebo. The intravenous placebo will be normal saline, which will be administered at 24 hourly interval for 3 days.
Sponsors
Monash Newborn, Monash Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Days to 14 Days
Healthy volunteers
No
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 Decision not-to-treat by the attending neonatologist
Outcome results
None listed