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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000754640

Acronym

The OVID Trial

Enrollment

Registered

2014-07-16

Start date

2014-08-01

Completion date

2015-07-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The ductus arteriosus DA is a blood vessel that connecting the two major vessels exiting the heart. It is a normal structure that is present in every baby before birth and closes very soon after birth in healthy term babies. In babies born prematurely before 32 weeks gestation, the DA can continue to remain open (or patent –PDA). The continual presence of the PDA in preterm infants may cause ongoing breathing difficulties, feeding problems or blood pressure issues. The doctors looking after your baby will generally want to give medication to close the PDA. The standard treatment is to use a medication called ibuprofen given as an intravenous injection. Recently, doctors is Australia have become aware of reports from other centres overseas that suggest paracetamol (a common medication for fever and pain) may be as effective as intravenous ibuprofen to help close the PDA. However, these reports currently do not provide sufficient scientific proof yet to guide doctors here to use to paracetamol routinely to treat PDAs. Therefore we propose to conduct a research study to compare whether oral paracetamol is as effective as intravenous ibuprofen in treating PDAs.

Interventions

Paracetamol: 15 mg/kg administered every 6 hours for a total of 3 days via nasogastric tube. This is defined as a treatment course of paracetamol.

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 10 Days

Healthy volunteers

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

Outcome results