Clinical Trial: Paracetamol and Patent Ductus Arteriosus (PDA)

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Summary: 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.
Sponsor: Shaare Zedek Medical Center

Current Primary Outcome: Closure of the Ductus [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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:

• 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

Information By: Shaare Zedek Medical Center

Dates:
Date Received: February 6, 2011
Date Started: April 2012
Date Completion:
Last Updated: December 18, 2012
Last Verified: December 2012