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Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.

NCT02056223 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-11-04

No results posted yet for this study

Summary

Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.

Conditions

  • Ductus Arteriosus Patent
  • Respiratory Distress Syndrome

Interventions

DRUG

Intravenous paracetamol

15 mg/Kg every 6 hours for three days

DRUG

Intravenous ibuprofen

10 -5-5 mg/Kg once a day for three days

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Paola Lago, MD · Women's and Children's Health Department- AO- University of Padua

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
36 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056223 on ClinicalTrials.gov