Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants. (PARIDA)

October 30, 2019 updated by: Paola Lago, University of Padova

Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial.

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The objective of this trial is to compare the efficacy and safety of 2 therapeutic regimens for PDA treatment in a population of preterm newborns of gestational age (GA) <31+6 weeks with respiratory distress syndrome (RDS) and HsPDA:

  • Group A: experimental boluses of paracetamol at 15 mg/Kg four time a day for three consecutive days.
  • Group B: standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.

The primary objective of the study is: to evaluate the efficacy of paracetamol versus standard ibuprofen regimen, by comparing the rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria)

The secondary objective of the study is: to evaluate the safety of the above 2 therapeutic regimens in term of incidence of transient renal impairment, intraventricular hemorrhage (IVH) or other bleeding disorders, necrotizing enterocolitis (NEC) and isolated bowel perforation (without signs of NEC), incidence of sign of liver toxicity.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy, 35128
        • NICU, Women's and Children's Health Department, Azienda Ospedaliera-University of Padua

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inborn neonates
  • preterm neonates ≤ 31+ 6 days weeks gestation
  • newborns with HsPDA
  • parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

  • Serum creatinine concentration greater than 1,5 mg/dl (132MMole/L)
  • Urine output less than 1 ml/Kg/h
  • Severe IVH (> grade II according to Volpe classification)
  • Clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate)
  • Necrotizing enterocolitis or marked abdominal distention with gastric bile residuals
  • Thrombocyte count of less than 50.000/mm3
  • Proved Sepsis
  • Severe coagulopathy or liver failure
  • Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0
  • Known genetic or chromosomal disorders
  • Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paracetamol
Boluses of intravenous paracetamol at 15 mg/Kg four time a day for three consecutive days.
Drug: Intravenous paracetamol
15 mg/Kg every 6 hours for three days
Other Names:
  • Paracetamol i.v.
Active Comparator: Intravenous ibuprofen
Standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.
Drug: Intravenous ibuprofen
10 -5-5 mg/Kg once a day for three days
Other Names:
  • Pedea i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PDA pharmacological closure
Time Frame: Partecipants will be evaluated at the end of first and second course, at an expected avarage of 8 days of life (DOL)
The rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria) in paracetamol versus ibuprofen group
Partecipants will be evaluated at the end of first and second course, at an expected avarage of 8 days of life (DOL)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oliguria
Time Frame: In the first 14 days of life
Rate of oliguria defined as a reduction on urine output less than 1ml/Kg/h,
In the first 14 days of life

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Necrotizing enterocolitis (NEC)
Time Frame: In the first 14 days of life
Rate of NEC in the paracetamol and ibuprofen group
In the first 14 days of life
Intraventricular haemorrhage (IVH) or death
Time Frame: Within 28 days of life
Rate of intraventricular haemorrhage (IVH) or death within 28 days of life (composite outcome).
Within 28 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Anticipated)

October 31, 2019

Study Completion (Anticipated)

October 31, 2019

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARIDA 01/2013
  • 2013-004955-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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