Paracetamol and Patent Ductus Arteriosus (PDA)

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 2

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Paracetamol; Drug: D5W; Drug: NSAID

Study type: Interventional

Funder types: Other

Identifiers

NCT01291654

SZMC-Hammerman-Acamol-2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 days to 2 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Paracetamol

Experimental group

Description:

Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days

Treatment:

Drug: Paracetamol

NSAID

Experimental group

Description:

Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr

Treatment:

Drug: D5W

Drug: NSAID