{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:54:30Z","timestamp":1793332470977,"version":"4.5.0"},"reference-count":39,"publisher":"American Medical Association (AMA)","issue":"16","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,10,28]]},"abstract":"\n Importance<\/jats:title>\n Extremely preterm infants are at high risk for bronchopulmonary dysplasia (BPD) and death. Multiple small randomized clinical trials showed that a combination of budesonide with surfactant compared with surfactant alone reduced BPD or death.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine if early intratracheal administration of a combination of budesonide (0.25 mg\/kg) mixed with surfactant, compared with surfactant alone, reduces physiologic BPD or death by 36 weeks\u2019 postmenstrual age in extremely preterm infants.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This double-masked randomized clinical trial was conducted from April 2021 to June 2024 in the 17 centers of the United States Neonatal Research Network. Infants 22 to 28 weeks\u2019 gestation or 401 to 1000 g birth weight were enrolled after clinical decision to give surfactant, with the first dose of surfactant being study drug (prior surfactant was an exclusion criterion).<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Infants were randomly allocated 1:1 to receive 1 to 2 doses of budesonide\u2009+\u2009surfactant (poractant alfa) or surfactant alone via endotracheal tube within 50 hours of birth.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was physiologic BPD or death by 36 weeks\u2019 postmenstrual age. There were 5 prespecified secondary outcomes and multiple prespecified exploratory and safety outcomes.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The trial was stopped with 641 infants enrolled (55.3% of 1160 planned; mean birth weight, 810 g [SD, 256 g]; gestational age, 25.9 weeks [SD, 1.9 weeks]), because interim analysis at 50% enrollment reached the prespecified futility threshold. The incidence of BPD or death was 68.5% in the budesonide\u2009+\u2009surfactant group and 67.9% in the surfactant-alone group (adjusted relative risk [RR], 1.00 [95% CI, 0.90-1.11]). No differences were noted in mortality (15.3% vs 13.2%; adjusted RR, 1.13 [95% CI, 0.78-1.64]) or BPD among survivors to 36 weeks\u2019 postmenstrual age (62.9% vs 63.0%; adjusted RR, 0.99 [95% CI, 0.87-1.12]). More infants who received budesonide\u2009+\u2009surfactant compared with surfactant alone had hyperglycemia (66.7% vs 49.8%; adjusted RR, 1.33 [95% CI, 1.17-1.51]).<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this large multicenter trial, the combination of budesonide with surfactant did not reduce the risk of BPD or death at 36 weeks\u2019 postmenstrual age in extremely preterm infants.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04545866<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.16450","type":"journal-article","created":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T15:30:29Z","timestamp":1759246229000},"page":"1452","source":"Crossref","is-referenced-by-count":19,"title":["Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants"],"prefix":"10.1001","volume":"334","author":[{"given":"Namasivayam","family":"Ambalavanan","sequence":"first","affiliation":[{"name":"Division of Neonatology, University of Alabama at Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waldemar A.","family":"Carlo","sequence":"additional","affiliation":[{"name":"Division of Neonatology, University of Alabama at Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayla J.","family":"Nowak","sequence":"additional","affiliation":[{"name":"Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura Elizabeth","family":"Wiener","sequence":"additional","affiliation":[{"name":"Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirley S.","family":"Cosby","sequence":"additional","affiliation":[{"name":"Division of Neonatology, University of Alabama at Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhay J.","family":"Bhatt","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Mississippi Medical Center, Jackson"}],"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":"Brenda B.","family":"Poindexter","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Keszler","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, The Warren Alpert Medical School of Brown University, Providence, Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl T.","family":"D\u2019Angio","sequence":"additional","affiliation":[{"name":"Division of Neonatology, University of Rochester School of Medicine and Dentistry, Rochester, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luc P.","family":"Brion","sequence":"additional","affiliation":[{"name":"Parkland Memorial Hospital, University of Texas Southwestern Medical Center at Dallas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek","family":"Narendran","sequence":"additional","affiliation":[{"name":"Cincinnati Children\u2019s Hospital Medical Center, University of Cincinnati Hospital, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carrie A.","family":"Rau","sequence":"additional","affiliation":[{"name":"University of Utah Health Sciences Center, Salt Lake City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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