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Clinical Trials/ACTRN12616001517460
ACTRN12616001517460
Terminated
Phase 2

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

Timothy Schindler0 sites58 target enrollmentNovember 3, 2016
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ConditionsPatent ductus arteriosusCardiovascular - Other cardiovascular diseasesReproductive Health and Childbirth - Complications of newborn

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Patent ductus arteriosus
Sponsor
Timothy Schindler
Enrollment
58
Status
Terminated
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 3, 2016
End Date
July 3, 2019
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Timothy Schindler

Eligibility Criteria

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
  • •\- \>30% right to left shunt

Outcomes

Primary Outcomes

Not specified

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