Paracetamol and Patent Ductus Arteriosus (PDA)

Patent Ductus Arteriosus Clinical Trial

Official title:

Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291654
• Other study ID #: SZMC-Hammerman-Acamol-2011
• Status: Recruiting
• Phase: Phase 2
• First received: February 6, 2011
• Last updated: December 18, 2012
• Start date: April 2012

Study information

• Verified date: December 2012
• Source: Shaare Zedek Medical Center
• Contact: Cathy Hammerman, MD
• Phone: +9722666-6238
• Email: cathy[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Paracetamol
po Paracetamol 15 mg/kg every 6 hours x 3 days
• 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).
• 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.

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of the Ductus		3 days	No
Secondary	Absence of peripheral vasoconstriction	Doppler flow velocity in anterior cerebral artery, superior mesenteric artery and renal artery will be measured before and after pharmacologic treatment.	48 hours	Yes
Secondary	Absence of hepatotoxicity	Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment	1 week	Yes