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Trial record 66 of 424 for:    shaare zedek

Paracetamol and Patent Ductus Arteriosus (PDA)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Cathy Hammerman, Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE February 6, 2011
First Posted Date  ICMJE February 8, 2011
Last Update Posted Date December 19, 2012
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
Closure of the Ductus [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01291654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
  • 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.
  • Absence of hepatotoxicity [ Time Frame: 1 week ]
    Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatiment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paracetamol and Patent Ductus Arteriosus (PDA)
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patent Ductus Arteriosus
Intervention  ICMJE
  • Drug: Paracetamol
    po Paracetamol 15 mg/kg every 6 hours x 3 days
  • 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.
Study Arms  ICMJE
  • Experimental: Paracetamol
    Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days
    Intervention: Drug: Paracetamol
  • Experimental: NSAID
    Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr
    Interventions:
    • Drug: NSAID
    • Drug: D5W
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291654
Other Study ID Numbers  ICMJE SZMC-Hammerman-Acamol-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cathy Hammerman, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cathy Hammerman, MD Hebrew University Faculty of Medicine
PRS Account Shaare Zedek Medical Center
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP