Acetaminophen versus ibuprofen in the management of hemodynamically significant patent ductus arteriosus in very low birth weight infants: a randomized controlled trial

niversity of Concepción0 个研究点目标入组 120 人开始时间: 2023年9月17日最近更新: 2023年9月26日

试验速览

暂无简介。

•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

•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)

发起方

niversity of Concepción