Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants
Rattachement africain : us, Cameroun. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Importance: 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. Objective: 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' postmenstrual age in extremely preterm infants. Design, Setting, and Participants: 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' 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). Interventions: Infants were randomly allocated 1:1 to receive 1 to 2 doses of budesonide + surfactant (poractant alfa) or surfactant alone via endotracheal tube within 50 hours of birth. Main Outcomes and Measures: The primary outcome was physiologic BPD or death by 36 weeks' postmenstrual age. There were 5 prespecified secondary outcomes and multiple prespecified exploratory and safety outcomes. Results: 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 + surfactant 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' postmenstrual age (62.9% vs 63.0%; adjusted RR, 0.99 [95% CI, 0.87-1.12]). More infants who received budesonide + surfactant compared with surfactant alone had hyperglycemia (66.7% vs 49.8%; adjusted RR, 1.33 [95% CI, 1.17-1.51]). Conclusions and Relevance: In this large multicenter trial, the combination of budesonide with surfactant did not reduce the risk of BPD or death at 36 weeks' postmenstrual age in extremely preterm infants. Trial Registration: ClinicalTrials.gov Identifier: NCT04545866.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants
- Date Crossref
- 28/10/2025
- Éditeur
- American Medical Association (AMA)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Alabama at Birmingham Division of Neonatology pays non établi dans la noticeUniversité ou école supérieure
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RTI International pays non établi dans la noticeOrganisation à but non lucratif
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Jackson Memorial Hospital pays non établi dans la noticeÉtablissement de santé
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University of Mississippi Medical Center Department of Pediatrics pays non établi dans la noticeÉtablissement de santé
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University of New Mexico Department of Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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University of New Mexico Health Sciences Center pays non établi dans la noticeUniversité ou école supérieure
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Emory University Department of Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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Brown University Department of Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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University of Rochester Division of Neonatology pays non établi dans la noticeUniversité ou école supérieure
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Parkland Memorial Hospital pays non établi dans la noticeÉtablissement de santé
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Cincinnati Children's Hospital Medical Center pays non établi dans la noticeÉtablissement de santé
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University of Utah pays non établi dans la noticeUniversité ou école supérieure
Division of Neonatology — University of Alabama at Birmingham, RTI International et Jackson Memorial Hospital, avec 9 autres affiliations. Pays d’affiliation : Cameroun.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.