Paracetamol and Patent Ductus Arteriosus (PDA)

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

Paracetamol and Patent Ductus Arteriosus (PDA)

Official Title

Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate

Brief Summary

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Closure of the Ductus

Secondary Outcome

 Absence of peripheral vasoconstriction

Condition

Patent Ductus Arteriosus

Intervention

Paracetamol

Study Arms / Comparison Groups

 Paracetamol
Description:  Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

April 2012


Primary Completion Date

December 2014

Eligibility 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.
      

Gender

All

Ages

N/A - 2 Weeks

Accepts Healthy Volunteers

No

Contacts

Cathy Hammerman, MD, +9722666-6238, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT01291654

Organization ID

SZMC-Hammerman-Acamol-2011


Responsible Party

Principal Investigator

Study Sponsor

Shaare Zedek Medical Center


Study Sponsor

Cathy Hammerman, MD, Principal Investigator, Hebrew University Faculty of Medicine


Verification Date

December 2012