دورية أكاديمية
Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome The OPTIMIST-A Randomized Clinical Trial
| العنوان: | Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome The OPTIMIST-A Randomized Clinical Trial |
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| المؤلفون: | Dargaville, Peter A., Kamlin, C. Omar F., Orsini, Francesca, Wang, Xiaofang, De Paoli, Antonio G., Kutman, H. Gozde Kanmaz, Cetinkaya, Merih, Kornhauser-Cerar, Lilijana, Derrick, Matthew, Ozkan, Hilal, Hulzebos, Christian, Schmolzer, 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., Bhatia, Risha, Sullivan, Carol L., Shinwell, Eric S., Dyson, Amanda, Barker, David P., Kugelman, Amir, Donovan, Tim J., Tauscher, Markus K., Murthy, Vadivelam, Ali, Sanoj K. M., Yossuck, Pete, Clark, Howard W., Soll, Roger F., Carlin, John B., Davis, Peter G. |
| المصدر: | OPTIMIST-A Trial Investigators , Dargaville , P A , Kamlin , C O F , Orsini , F , Wang , X , De Paoli , A G , Kutman , H G K , Cetinkaya , M , Kornhauser-Cerar , L , Derrick , M , Ozkan , H , Hulzebos , C , Schmolzer , G M , Aiyappan , A , Lemyre , B , Kuo , S , Rajadurai , V S , O'Shea , J , Biniwale , M , Ramanathan , R , Kushnir , A , Bader , D , Thomas , .... |
| سنة النشر: | 2021 |
| المجموعة: | University of Groningen research database |
| مصطلحات موضوعية: | NASAL CPAP, BIRTH, VENTILATION, MANAGEMENT, FAILURE, IMPACT |
| الوصف: | IMPORTANCE The benefits of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome are uncertain. OBJECTIVE To examine the effect of selective application of MIST at a low fraction of inspired oxygen threshold on survival without bronchopulmonary dysplasia (BPD). DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial including 485 preterm infants with a gestational age of 25 to 28 weeks who were supported with continuous positive airway pressure (CPAP) and required a fraction of inspired oxygen of 0.30 or greater within 6 hours of birth. The trial was conducted at 33 tertiary-level neonatal intensive care units around the world, with blinding of the clinicians and outcome assessors. Enrollment took place between December 16, 2011, and March 26, 2020; follow-up was completed on December 2, 2020. INTERVENTIONS Infants were randomized to the MIST group (n = 241) and received exogenous surfactant (200 mg/kg of poractant alfa) via a thin catheter or to the control group (n = 244) and received a sham (control) treatment; CPAP was continued thereafter in both groups unless specified intubation criteria were met. MAIN OUTCOMES AND MEASURES The primary outcome was the composite of death or physiological BPD assessed at 36 weeks' postmenstrual age. The components of the primary outcome (death prior to 36 weeks' postmenstrual age and BPD at 36 weeks' postmenstrual age) also were considered separately. RESULTS Among the 485 infants randomized (median gestational age, 27.3 weeks; 241 [49.7%] female), all completed follow-up. Death or BPD occurred in 105 infants (43.6%) in the MIST group and 121 (49.6%) in the control group (risk difference [RD], -63% [95% CI, -14.2% to 1.6%); relative risk [RR], 0.87 [95% CI, 0.74 to 1.03]; P = .10). Incidence of death before 36 weeks' postmenstrual age did not differ significantly between groups (24 [10.0%) in MIST vs 19 [7.8%) in control; RD, 2.1% [95% CI, -3.6% to 7.8%); RR, 1.27 [95% CI, 0.63 ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://research.rug.nl/en/publications/1f7b6e0b-502e-4007-833a-2e928090b15dTest |
| DOI: | 10.1001/jama.2021.21892 |
| الإتاحة: | https://doi.org/10.1001/jama.2021.21892Test https://hdl.handle.net/11370/1f7b6e0b-502e-4007-833a-2e928090b15dTest https://research.rug.nl/en/publications/1f7b6e0b-502e-4007-833a-2e928090b15dTest https://pure.rug.nl/ws/files/198373948/Effect_of_Minimally_Invasive_Surfactant_Therapy_vs_Sham_Treatment_on_Death_or_Bronchopulmonary_Dysplasia_in_Preterm_Infants_With_Respiratory_Distress_Syndrome.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.B68A2C5 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jama.2021.21892 |
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