Paracetamol and Patent Ductus Arteriosus (PDA)
Information source: Shaare Zedek Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patent Ductus Arteriosus
Intervention: Paracetamol (Drug); NSAID (Drug); D5W (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Shaare Zedek Medical Center Official(s) and/or principal investigator(s): Cathy Hammerman, MD, Principal Investigator, Affiliation: Hebrew University Faculty of Medicine
Overall contact: Cathy Hammerman, MD, Phone: +9722666-6238, Email: cathy@cc.huji.ac.il
Summary
The investigators propose that paracetamol will be similarly effective to ibuprofen in
treating PDA in the premature neonate, with fewer side effects.
Clinical Details
Official title: Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Closure of the Ductus
Secondary outcome: Absence of peripheral vasoconstrictionAbsence of hepatotoxicity
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.
Eligibility
Minimum age: N/A.
Maximum age: 2 Weeks.
Gender(s): Both.
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.
Locations and Contacts
Cathy Hammerman, MD, Phone: +9722666-6238, Email: cathy@cc.huji.ac.il
Shaare Zedek Medical Center, Jerusalem 91031, Israel; Recruiting Cathy Hammerman, MD, Phone: +9722666-6238, Email: cathy@cc.huji.ac.il Cathy Hammerman, MD, Principal Investigator
Additional Information
Starting date: April 2012
Last updated: December 18, 2012
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