Acetaminophen versus ibuprofen in the management of hemodynamically significant patent ductus arteriosus in very low birth weight infants

Not Applicable

Completed

• Conditions: Patent ductus arteriosus in the very low birth weight premature newborn; Neonatal Diseases

• Registration Number: ISRCTN72579770
• Lead Sponsor: niversity of Concepción

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-31
• Study Start: 2023-09-17
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Preterm newborns between 25+0 – 31+6 weeks of gestational age and/or =1500 g of birth weight
2. Echocardiographic diagnosis of hemodynamically significant PDA within the first 2 weeks after birth
3. Admitted to the neonatal intensive care unit of Guillermo Grant Benavente Hospital

Exclusion Criteria

1. Major congenital malformations, fetal hydrops, complex or ductus-dependent congenital heart disease; septic shock
grade III and IV intracranial hemorrhage
2. Renal failure with urine output <1 cc/kg/hr in the previous 24 h
3. Serum creatinine concentration >1.5 mg/dl; platelet count <50,000 mm³
4. Major bleeding (defined as the presence of massive hematuria and/or blood in tracheal aspirate), hyperbilirubinemia in the range of exchange transfusion
5. Confirmed necrotizing enterocolitis (Bell stage > II)
6. Liver dysfunction defined as elevation of liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) over two times the upper limit of normal range (ALT 6-50 U/L and AST 35-140 U/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified