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Paracetamol and Patent Ductus Arteriosus (PDA)

Information source: Shaare Zedek Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
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 vasoconstriction

Absence 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

Page last updated: February 07, 2013

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