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Paracetamol and Patent Ductus Arteriosus (PDA)

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. Identifier: NCT01291654
Recruitment Status : Unknown
Verified December 2012 by Cathy Hammerman, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : February 8, 2011
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):
Cathy Hammerman, Shaare Zedek Medical Center

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

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Paracetamol Drug: NSAID Drug: D5W Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate
Study Start Date : April 2012
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Closure of the Ductus [ Time Frame: 3 days ]

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

  2. Absence of hepatotoxicity [ Time Frame: 1 week ]
    Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01291654

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Contact: Cathy Hammerman, MD +9722666-6238
Contact: Alona Bin-Nun, MD +9722666-6757

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Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Cathy Hammerman, MD    +9722666-6238   
Principal Investigator: Cathy Hammerman, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Cathy Hammerman, MD Hebrew University Faculty of Medicine
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Responsible Party: Cathy Hammerman, Prof. Pediatrics, Shaare Zedek Medical Center Identifier: NCT01291654    
Other Study ID Numbers: SZMC-Hammerman-Acamol-2011
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012
Keywords provided by Cathy Hammerman, Shaare Zedek Medical Center:
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs