Paracetamol and Patent Ductus Arteriosus (PDA)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Acetaminophen; Indomethacin

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.