Paracetamol and Patent Ductus Arteriosus (PDA)

Phase 2

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Paracetamol; Drug: NSAID; Drug: D5W

• Registration Number: NCT01291654
• Lead Sponsor: Shaare Zedek Medical Center

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 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.

Study Timeline

• Study First Submitted: 2011-02-06
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Study Start: 2012-04
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paracetamol	Paracetamol	Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days
NSAID	NSAID	Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr
NSAID	D5W	Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr

Primary Outcome Measures

Name	Time	Method
Closure of the Ductus	3 days

Secondary Outcome Measures

Name	Time	Method
Absence of peripheral vasoconstriction	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	1 week	Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel