Early PARacetamol (EPAR) to promote early closure of the ductus arteriosus in preterm infants

Phase 2

• Conditions: Patent ductus arteriosus; Cardiovascular - Other cardiovascular diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12616001517460
• Lead Sponsor: Timothy Schindler

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-03
• Study Completion: 2019-07-03
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Preterm infants <6 hours old
Born at <29 weeks gestation
Informed parental consent
Ductus arteriosus characteristics
- Patent >1 mm
- <30% right to left shunt

Exclusion Criteria

Known congenital anomalies
Haemodynamic instability (>1 ionotropic agent)
Abnormal baseline liver function
- Transaminases >50% above upper reference range
- Bilirubin above local guideline for exchange transfusion
Ductus arteriosus characteristics
- <1 mm
- >30% right to left shunt

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any intervention for management of PDA up to five days[The need for medical or surgical intervention will be assessed by review of the medical record at 5 days of life]