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Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02002741
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Condition or disease Intervention/treatment Phase
Ductus Arteriosus, Patent Drug: Paracetamol Drug: Placebo Phase 2 Phase 3

Detailed Description:
Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
Actual Study Start Date : August 1, 2014
Estimated Primary Completion Date : May 31, 2017
Estimated Study Completion Date : December 31, 2017


Arm Intervention/treatment
Active Comparator: Ibuprofen + Paracetamol

Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses

+ Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses

Drug: Paracetamol
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
Other Names:
  • Acetaminophen
  • Acamol
Placebo Comparator: Ibuprofen + Placebo

Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses

+ Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.

Drug: Placebo
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Other Name: NaCl 0.9%



Primary Outcome Measures :
  1. The incidence of patent ductus arteriosus closure [ Time Frame: 3-10 days after first dose of Ibuprofen + study drug ]
    By echocardiography


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: until discharge home (usually within 2-3 months since recruitment) ]
    Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records

  2. The need for surgical ligation for PDA [ Time Frame: 3-21 days after first dose of Ibuprofen + study drug ]
    need for surgical ligation for PDA



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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants born at 24-37 gestational age
  • diagnosis of Hemodynamically significant patent ductus arteriosus
  • Medical staff decided to treat with Ibuprofen
  • Parents have signed informed consent

Exclusion Criteria:

  • Contraindication for ibuprofen
  • Alanine transaminase /Aspartate transaminase≥ 200 U/L
  • Significant congenital heart disease

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): NCT02002741


Contacts
Contact: Ori Hochwald, MD 972-4-8542219 o_hochwald@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Ori Hochwald, MD    972-4-8542219    o_hochwald@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02002741     History of Changes
Other Study ID Numbers: IBUACA CTIL
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rambam Health Care Campus:
patent ductus arteriosus
PDA
Preterm
Infant
Electrocardiography
Paracetamol
Acamol
ibuprofen
Placebo

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action