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

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ClinicalTrials.gov Identifier: NCT02056223
Recruitment Status : Unknown
Verified June 2017 by Paola Lago, University of Padua.
Recruitment status was:  Recruiting
First Posted : February 5, 2014
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Paola Lago, University of Padua

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.

Condition or disease Intervention/treatment Phase
Ductus Arteriosus Patent Respiratory Distress Syndrome Drug: Intravenous paracetamol Drug: Intravenous ibuprofen Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial.
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019


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 Name: 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 Name: Pedea i.v.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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,


Other Outcome Measures:
  1. Necrotizing enterocolitis (NEC) [ Time Frame: In the first 14 days of life ]
    Rate of NEC in the paracetamol and ibuprofen group

  2. 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).



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056223


Contacts
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Contact: Paola Lago, MD 0039 049 821 ext 3545 paolalago9@gmail.com
Contact: Sabrina Salvadori, MD 0039 049 821 ext 3546 sabrina.salvadori@sanita.padova.it

Locations
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Italy
NICU, Women's and Children's Health Department, Azienda Ospedaliera-University of Padua Recruiting
Padua, Italy, 35128
Contact: Paola Lago, MD    0039 049 821 ext 3545    paola.lago@aopd.veneto.it   
Contact: Sabrina Salvadori, MD    0039 049 821 ext 3546    sabrina.salvadori@aopd.veneto.it   
Principal Investigator: Paola Lago, MD         
Sub-Investigator: Sabrina Salvadori, MD         
Sub-Investigator: Anna Chiara Frigo, MSc         
Sub-Investigator: Roberto Padrini, MD         
Sub-Investigator: Daniel Nardo, MD         
Sub-Investigator: Eugenio Baraldi, MD         
Sponsors and Collaborators
University of Padua
Investigators
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Principal Investigator: Paola Lago, MD Women's and Children's Health Department- AO- University of Padua

Publications of Results:
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Responsible Party: Paola Lago, MD, University of Padua
ClinicalTrials.gov Identifier: NCT02056223     History of Changes
Other Study ID Numbers: PARIDA 01/2013
2013-004955-19 ( EudraCT Number )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by Paola Lago, University of Padua:
Patent ductus arteriosus
Preterm infant
Paracetamol
Ibuprofen
Additional relevant MeSH terms:
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Ibuprofen
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Ductus Arteriosus, Patent
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics