Treatment of Patent Ductus Arteriosus with Paracetamol

Phase 3

Recruiting

• Conditions: Patent ductus arteriosus in very low birth weight neonates; Reproductive Health and Childbirth - Complications of newborn; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000289718
• Lead Sponsor: Sapienza University of Rome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Neonates with gestational age < 32 weeks and birth weight < 1500 g and with echocardiographic evidence of patent ductus arteriosus and contraindication to or failure of conventional medical therapy with COX inhibitors (ibuprofen or indomethacin) consecutively observed in Neonatal Intensive Care Unit are eligible for the trial. In all infants, color-doppler ultrasound will be performed at 24-48 hrs after birth to evaluate patency of ductus arteriosus and shunting. Elegibility of a neonate is defined by the presence at color-doppler ultrasound of at last one of the following criteria: 1. transductal diameter =/>1.5 mm, 2. reverse diastolic flow or absent diastolic flow in the descending aorta or in the superior mesenteric artery, anterior or middle cerebral arteries or renal artery, 3. unrestrictive pulsatile transductal flow (DA V max <2 m/s), 4. left-atrium-to-aortic-root ratio =/>1.5. Controindications to NSAIDs therapy are: reduced urine output (< 1 ml/kg/h) during the preceding 8 hours or other signs of renal failure, liver failure, intraventricular hemorrhage, a platelet count < 60,000/mm3, hyperbilirubinemia (defined as total bilirubin > 15 mg/dl), gastrointestinal bleeding and signs of feeding intolerance. Failure of NSAIDs treatment is defined by the presence of a patent ductus at the end of a single course of treatment with ibuprofen (loading dose at 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours) or indomethacin (three doses at 0,2 mg/kg every 12 hours).

Exclusion Criteria

Liver disease, hemolytic anemia, family history of G6PD deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified