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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056223
Recruitment Status : Suspended (We enrolled only 53 patients)
First Posted : February 5, 2014
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Paola Lago, University of Padova

Tracking Information
First Submitted Date  ICMJE February 3, 2014
First Posted Date  ICMJE February 5, 2014
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE January 9, 2017
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
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,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 4, 2014)
  • Necrotizing enterocolitis (NEC) [ Time Frame: In the first 14 days of life ]
    Rate of NEC in the paracetamol and ibuprofen group
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.
Official Title  ICMJE Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial.
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ductus Arteriosus Patent
  • Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: Intravenous paracetamol
    15 mg/Kg every 6 hours for three days
    Other Name: Paracetamol i.v.
  • Drug: Intravenous ibuprofen
    10 -5-5 mg/Kg once a day for three days
    Other Name: Pedea i.v.
Study Arms  ICMJE
  • Experimental: paracetamol
    Boluses of intravenous paracetamol at 15 mg/Kg four time a day for three consecutive days.
    Intervention: Drug: Intravenous paracetamol
  • Active Comparator: Intravenous ibuprofen
    Standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.
    Intervention: Drug: Intravenous ibuprofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 72 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056223
Other Study ID Numbers  ICMJE PARIDA 01/2013
2013-004955-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paola Lago, University of Padova
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paola Lago, MD Women's and Children's Health Department- AO- University of Padua
PRS Account University of Padova
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP