Acetaminophen vs Indomethacin in Treating hsPDA

• Status: Terminated
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tennessee
• Treatments: Acetaminophen; Indomethacin

Criteria

Inclusion Criteria:

• Gestational age at birth 22 weeks to 31 6/7 weeks.

• Birth weight ≤ 1500 grams

• Day of life ≤ 21 days

• ECHO findings:

Left-to-right ductal flow AND 2 of the following 3:

• Ductal size > 1.5mm at smallest diameter

• Reversal of flow in descending aorta

• Left atrial size to aortic root ratio >1.5

• Platelet count > 50,000

Exclusion Criteria:

• Ductal dependent congenital heart disease

• Major congenital anomaly

• Life-threatening infection

• Urine output < 1cc/kg/hr in prior 8 hours

• Serum creatinine > 1.8 mg/dL

• Hyperbilirubinemia requiring exchange transfusion

• Active NEC Stage 2 or 3 using Bell's staging criteria

• Active intestinal perforation

• Liver dysfunction [2x upper limit of normal for aspartate aminotransferase(AST) and/or alanine aminotransferase (ALT)]

• Active GI bleeding

• Concurrent hydrocortisone use

• Known IVH Grade 3 or 4