Oral paracetamol versus intravenous Ibuprofen for the treatment of patent Ductus arteriosus in premature infants: A Pilot Randomised Trial (The OVID Trial)

Phase 3

Withdrawn

• Conditions: Patent ductus arteriosus; Prematurity; Reproductive Health and Childbirth - Childbirth and postnatal care; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000754640
• Lead Sponsor: Monash Newborn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PDA closure OR reduction in size by >50%; assessed by echocardiography.[Within 72 hours after completion of first medical treatment course]

Secondary Outcome Measures

Name	Time	Method
Rate of PDA closure after the first course of medical treatment, assessed by echocardiography.[Within 72 hours after completion of first medical treatment course];Size of PDA after the first course of medical treatment, assessed by echocardiography.[Within 72 hours after completion of first medical treatment course];Rate of PDA closure after the second course of medical treatment, assessed by echocardiography.[Within 72 hours after completion of the second medical treatment course];Need for re-treatment or surgical ligation after 2 completed courses of medical treatment[During NICU admission]