title: Treatment of persistent patent ductus arteriosus in preterm infants: time to accept the null hypothesis?
abstract: Medical and surgical interventions are widely used to close a persistently patent ductus arteriosus in preterm infants. Objective evidence to support these practices is lacking, causing some to question their usage. Emerging evidence suggests that treatments that close the patent ductus may be detrimental. This review examines the history of and evidence underlying these treatments. Neither individual trials, pooled data from groups of randomized-controlled trials, nor critical examination of the immediate consequences of treatment provide evidence that medical or surgical closure of the ductus is beneficial in preterm infants. These conclusions are supported by sufficient evidence. Neither continued routine use of these treatments nor additional clinical trials using similar designs seems to be justified. A definitive trial, comparing current standard management with novel strategies not primarily intended to achieve ductal closure, may be necessary to resolve doubts regarding the quality or conduct of prior studies.
authors.affiliation: Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA 94304-1510, USA. benitzwe@stanford.edu
authors.forename: W E
authors.initials: WE
authors.lastname: Benitz
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D006348:Cardiac Surgical Procedures; D016001:Confidence Intervals; D004374:Ductus Arteriosus, Patent / Q000150:complications / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D007213:Indomethacin / Q000627:therapeutic use; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy / Q000601:surgery*; D008026:Ligation; D012127:Respiratory Distress Syndrome, Newborn / Q000150:complications; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen; D007213:Indomethacin