Paracetamol and Patent Ductus Arteriosus (PDA)
The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.
Patent Ductus Arteriosus
|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|
- Closure of the Ductus [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days
po Paracetamol 15 mg/kg every 6 hours x 3 days
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291654
|Contact: Cathy Hammerman, MDfirstname.lastname@example.org|
|Contact: Alona Bin-Nun, MDemail@example.com|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Cathy Hammerman, MD +9722666-6238 firstname.lastname@example.org|
|Principal Investigator: Cathy Hammerman, MD|
|Principal Investigator:||Cathy Hammerman, MD||Hebrew University Faculty of Medicine|