{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T11:57:56Z","timestamp":1793447876966,"version":"4.5.0"},"reference-count":30,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2026,2,17]]},"abstract":"\n Importance<\/jats:title>\n The management of patent ductus arteriosus (PDA) in preterm infants is controversial.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine whether expectant management compared with active treatment of a protocol-defined PDA in preterm infants decreases the incidence of death or bronchopulmonary dysplasia (BPD).<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n A randomized clinical trial including infants born at 22 to 28 weeks\u2019 gestation and diagnosed with a protocol-defined PDA between the age of 48 hours and 21 days at screening. The trial was conducted from December 2018 to December 2024 at 33 hospitals within the National Institute of Child Health and Human Development Neonatal Research Network. The final date of follow-up was June 2025.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Infants with PDA were randomized to expectant management (n\u2009=\u2009242) or active treatment (n\u2009=\u2009240; acetaminophen, ibuprofen, or indomethacin) to close the PDA.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was death or BPD at 36 weeks\u2019 postmenstrual age. The secondary outcomes included the components of the primary outcome and other morbidities of prematurity.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 482 infants were randomized (median gestational age, 25 weeks [IQR, 24 to 27 weeks]; median birth weight, 760 g [IQR, 620 to 935 g]). The trial was stopped for futility and safety after the 50% interim analysis for the primary outcome due to higher survival in the expectant management group. The incidence of death or BPD was 80.9% (195\/241) of infants in the expectant management group vs 79.6% (191\/240) of infants in the active treatment group (adjusted risk difference, 1.2% [95% CI, \u22125.7% to 8.1%];\n P<\/jats:italic>\n \u2009=\u2009.73). The incidence of death before 36 weeks\u2019 postmenstrual age was 4.1% (10\/241) of infants in the expectant management group vs 9.6% (23\/240) of infants in the active treatment group (adjusted risk difference, \u22125.6% [95% CI, \u221210.1% to \u22121.2%];\n P<\/jats:italic>\n \u2009=\u2009.01). Infections resulting in death occurred in 0.8% (2\/241) of infants in the expectant management group vs 3.8% (9\/240) of infants in the active treatment group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In extremely preterm infants with a protocol-defined PDA, death or BPD did not differ between the expectant management group and the active treatment group. Survival was substantially higher with expectant management.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT03456336<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.23330","type":"journal-article","created":{"date-parts":[[2025,12,9]],"date-time":"2025-12-09T18:30:20Z","timestamp":1765305020000},"page":"588","source":"Crossref","is-referenced-by-count":23,"title":["Expectant Management vs Medication for Patent Ductus Arteriosus in Preterm Infants"],"prefix":"10.1001","volume":"335","author":[{"given":"Matthew M.","family":"Laughon","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of North Carolina at Chapel Hill"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia M.","family":"Thomas","sequence":"additional","affiliation":[{"name":"Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristi L.","family":"Watterberg","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of New Mexico Health Sciences Center, Albuquerque"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen A.","family":"Kennedy","sequence":"additional","affiliation":[{"name":"McGovern Medical School, University of Texas Health Science Center, Houston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Keszler","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Warren Alpert Medical School, Brown University, Providence, Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namisavayam","family":"Ambalavanan","sequence":"additional","affiliation":[{"name":"Division of Neonatology, University of Alabama, Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis S.","family":"Davis","sequence":"additional","affiliation":[{"name":"Lucile Packard Children\u2019s Hospital Stanford, Stanford University, Palo Alto, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan L.","family":"Slaughter","sequence":"additional","affiliation":[{"name":"Nationwide Children\u2019s Hospital, College of Medicine, Ohio State University, Columbus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronnie","family":"Guillet","sequence":"additional","affiliation":[{"name":"Division of Neonatology, School of Medicine and Dentistry, University of Rochester, Rochester, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarah T.","family":"Colaizy","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Iowa, Iowa City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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