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Paracetamol and Patent Ductus Arteriosus (PDA)

This study is currently recruiting participants.
Verified December 2012 by Shaare Zedek Medical Center
Sponsor:
Information provided by (Responsible Party):
Cathy Hammerman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01291654
First received: February 6, 2011
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.


Condition Intervention Phase
Patent Ductus Arteriosus
 Drug: Paracetamol
Drug: NSAID
Drug: D5W
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Closure of the Ductus [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence of peripheral vasoconstriction [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Doppler flow velocity in anterior cerebral artery, superior mesenteric artery and renal artery will be measured before and after pharmacologic treatment.

  • Absence of hepatotoxicity [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol
Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days
 Drug: Paracetamol
po Paracetamol 15 mg/kg every 6 hours x 3 days
Experimental: NSAID
Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr
 Drug: NSAID
IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).
Drug: D5W
Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.

Detailed Description:

Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus

Exclusion Criteria:

  • Major congenital anomalies
  • Life-threatening infection
  • Active NEC and/or intestinal perforation
  • Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
  • Urine output <1 ml per kilogram per hour during the preceding 8 hours
  • Serum creatinine concentration of >1.6 mg %
  • Platelet count of <60,000 per cc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291654

Contacts
Contact: Cathy Hammerman, MD +9722666-6238 cathy@cc.huji.ac.il
Contact: Alona Bin-Nun, MD +9722666-6757 alona.binnun@gmail.com

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Cathy Hammerman, MD     +9722666-6238     cathy@cc.huji.ac.il    
Principal Investigator: Cathy Hammerman, MD            
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Cathy Hammerman, MD Hebrew University Faculty of Medicine
  More Information

No publications provided

Responsible Party: Cathy Hammerman, Prof. Pediatrics, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01291654     History of Changes
Other Study ID Numbers: SZMC-Hammerman-Acamol-2011
Study First Received: February 6, 2011
Last Updated: December 18, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
PDA
Paracetamol
Indomethacin
Ibuprofen

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013