Paracetamol Duct Action(PDA) Trial: Does paracetamol close a patent ductus arteriosus in premature infants?
- Conditions
- Patent ductus arteriosusCardiovascular - Normal development and function of the cardiovascular systemReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12611000741987
- Lead Sponsor
- A/Professor Martin Kluckow
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1.Babies with a persistent PDA born <33 weeks gestational age who are >4 weeks of postnatal age and tolerating at least 50% (i.e. 80ml/kg/day) of enteral feeds
2.Echocardiographic findings of a PDA with a Colour Doppler duct size more than 1.5mm with pulsatile pattern with or without oxygen and/or CPAP support.
3.Informed written parental consent
1.PDA with evidence of congestive cardiac failure, signs include tachycardia; venous congestion; high catecholamine levels; and, ultimately, insufficient cardiac output with poor perfusion and end-organ compromise.
2.Abnormal liver function tests :
a.Elevated alanine transaminase (twice normal level for corrected gestation)
b.Elevated aspartate transaminase (twice normal level for corrected gestation)
c.Elevated conjugated bilirubin (>80mmol/L)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Closure of the PDA confirmed by echocardiography[At 5 days post commencement of treatment]
- Secondary Outcome Measures
Name Time Method Paracetamol serum level - measured in blood using an immunoassay techique[Day 2 and Day 5]