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Dargaville, Peter A.; Kamlin, C. Omar F.; Orsini, Francesca; Wang, Xiaofang; De Paoli, Antonio G.; Kanmaz Kutman, H. Gozde; Cetinkaya, Merih; Kornhauser-Cerar, Lilijana; Derrick, Matthew; Özkan, Hilal; Hulzebos, Christian V.; Schmölzer, Georg M.; Aiyappan, Ajit; Lemyre, Brigitte; Kuo, Sheree; Rajadurai, Victor S.; O’Shea, Joyce; Biniwale, Manoj; Ramanathan, Rangasamy; Kushnir, Alla; Bader, David; Thomas, Mark R.; Chakraborty, Mallinath; Buksh, Mariam J.; [...]

Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants : Follow-Up of the OPTIMIST-A Randomized Clinical Trial : Follow-Up of the OPTIMIST-A Randomized Clinical Trial

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  • Medientyp: E-Artikel
  • Titel: Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants : Follow-Up of the OPTIMIST-A Randomized Clinical Trial : Follow-Up of the OPTIMIST-A Randomized Clinical Trial
  • Beteiligte: Dargaville, Peter A.; Kamlin, C. Omar F.; Orsini, Francesca; Wang, Xiaofang; De Paoli, Antonio G.; Kanmaz Kutman, H. Gozde; Cetinkaya, Merih; Kornhauser-Cerar, Lilijana; Derrick, Matthew; Özkan, Hilal; Hulzebos, Christian V.; Schmölzer, Georg M.; Aiyappan, Ajit; Lemyre, Brigitte; Kuo, Sheree; Rajadurai, Victor S.; O’Shea, Joyce; Biniwale, Manoj; Ramanathan, Rangasamy; Kushnir, Alla; Bader, David; Thomas, Mark R.; Chakraborty, Mallinath; Buksh, Mariam J.; [...]
  • Erschienen: American Medical Association (AMA), 2023
  • Erschienen in: JAMA
  • Sprache: Englisch
  • DOI: 10.1001/jama.2023.15694
  • ISSN: 0098-7484
  • Schlagwörter: General Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Importance</jats:title><jats:p>The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome remain to be definitively clarified.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years’ corrected age.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>Follow-up study of a randomized clinical trial with blinding of clinicians and outcome assessors conducted in 33 tertiary-level neonatal intensive care units in 11 countries. The trial included 486 infants with a gestational age of 25 to 28 weeks supported with continuous positive airway pressure (CPAP). Collection of follow-up data at 2 years’ corrected age was completed on December 9, 2022.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Infants assigned to MIST (n = 242) received exogenous surfactant (200 mg/kg poractant alfa) via a thin catheter; those assigned to the control group (n = 244) received sham treatment.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The key secondary outcome of death or moderate to severe NDD was assessed at 2 years’ corrected age. Other secondary outcomes included components of this composite outcome, as well as hospitalizations for respiratory illness and parent-reported wheezing or breathing difficulty in the first 2 years.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among the 486 infants randomized, 453 had follow-up data available (median gestation, 27.3 weeks; 228 females [50.3%]); data on the key secondary outcome were available in 434 infants. Death or NDD occurred in 78 infants (36.3%) in the MIST group and 79 (36.1%) in the control group (risk difference, 0% [95% CI, −7.6% to 7.7%]; relative risk [RR], 1.0 [95% CI, 0.81-1.24]); components of this outcome did not differ significantly between groups. Secondary respiratory outcomes favored the MIST group. Hospitalization with respiratory illness occurred in 49 infants (25.1%) in the MIST group vs 78 (38.2%) in the control group (RR, 0.66 [95% CI, 0.54-0.81]) and parent-reported wheezing or breathing difficulty in 73 (40.6%) vs 104 (53.6%), respectively (RR, 0.76 [95% CI, 0.63-0.90]).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>In this follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome supported with CPAP, MIST compared with sham treatment did not reduce the incidence of death or NDD by 2 years of age. However, infants who received MIST had lower rates of adverse respiratory outcomes during their first 2 years of life.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>anzctr.org.au Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336668&amp;amp;amp;isReview=true">ACTRN12611000916943</jats:ext-link></jats:p></jats:sec>