دورية أكاديمية
Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants: Follow-Up of the OPTIMIST-A Randomized Clinical Trial.
| العنوان: | Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants: Follow-Up of the OPTIMIST-A Randomized Clinical Trial. |
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| المؤلفون: | Dargaville PA; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.; Department of Paediatrics, Royal Hobart Hospital, Hobart, Tasmania, Australia., Kamlin COF; Neonatal Services, Royal Women's Hospital, Melbourne, Victoria, Australia.; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia., Orsini F; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Victoria, Australia., Wang X; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Victoria, Australia., De Paoli AG; Department of Paediatrics, Royal Hobart Hospital, Hobart, Tasmania, Australia., Kanmaz Kutman HG; Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey., Cetinkaya M; Division of Neonatology, Department of Pediatrics, Istanbul Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey., Kornhauser-Cerar L; Division of Gynaecology and Obstetrics, Department of Perinatology, University Medical Centre, Ljubljana, Slovenia., Derrick M; Division of Neonatology, Northshore University Health System, Evanston, Illinois., Özkan H; Division of Neonatology, Department of Pediatrics, Uludağ University Faculty of Medicine, Bursa, Turkey., Hulzebos CV; Division of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, the Netherlands., Schmölzer GM; Division of Neonatology, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada., Aiyappan A; Neonatal Services, Mercy Hospital for Women, Heidelberg, Victoria, Australia., Lemyre B; Department of Obstetrics, Gynecology, and Newborn Care, The Ottawa Hospital, Ottawa, Ontario, Canada., Kuo S; Department of Pediatrics, Kapi'olani Medical Center for Women and Children, Honolulu, Hawai'i., Rajadurai VS; Department of Neonatology, KK Women's and Children's Hospital, Duke-NUS Medical School, Singapore., O'Shea J; Neonatal Unit, Royal Hospital for Children, Glasgow, United Kingdom., Biniwale M; Division of Neonatology, Department of Pediatrics, Los Angeles County + USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, California., Ramanathan R; Division of Neonatology, Department of Pediatrics, Los Angeles County + USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, California., Kushnir A; Department of Pediatrics, Children's Regional Hospital, Cooper University Health Care, Camden, New Jersey., Bader D; Rappaport Faculty of Medicine, Department of Neonatology, Bnai Zion Medical Center, Technion, Haifa, Israel., Thomas MR; Department of Neonatal Medicine, Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom., Chakraborty M; Regional Neonatal Intensive Care Unit, University Hospital of Wales, Cardiff, United Kingdom., Buksh MJ; Newborn Service, Starship Child Health, Auckland Hospital, Auckland, New Zealand., Bhatia R; Monash Newborn, Monash Children's Hospital, Clayton, Victoria, Australia., Sullivan CL; Department of Neonatology, Singleton Hospital, Swansea, United Kingdom., Shinwell ES; Faculty of Medicine, Department of Neonatology, Ziv Medical Center, Bar-Ilan University, Tsfat, Israel., Dyson A; Department of Neonatology, Centenary Hospital for Women and Children, Canberra Hospital, Woden, New South Wales, Australia., Barker DP; Neonatal Intensive Care Unit, Dunedin Hospital, Dunedin, New Zealand., Kugelman A; Rappaport Faculty of Medicine, Department of Neonatology, Rambam Medical Center, Technion, Haifa, Israel., Donovan TJ; Division of Neonatology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Goss KCW; Neonatal Intensive Care Unit, Princess Anne Hospital, Southampton, United Kingdom., Tauscher MK; Division of Neonatology, Peyton Manning Children's Hospital, Ascension St Vincent, Indianapolis, Indiana., Murthy V; Neonatal Intensive Care Centre, The Royal London Hospital-Barts Health NHS Foundation Trust, London, United Kingdom., Ali SKM; Division of Neonatology, Sidra Medicine, Doha, Qatar., Clark HW; Faculty of Population Health Sciences, Neonatology, EGA Institute for Women's Health, University College London, London, United Kingdom., Soll RF; Division of Neonatal-Perinatal Medicine, Larner College of Medicine, The University of Vermont, Burlington., Johnson S; Infant Mortality and Morbidity Studies Research Group, Department of Population Health Sciences, University of Leicester, Leicester, United Kingdom., Cheong JLY; Neonatal Services, Royal Women's Hospital, Melbourne, Victoria, Australia.; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia., Carlin JB; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia., Davis PG; Neonatal Services, Royal Women's Hospital, Melbourne, Victoria, Australia.; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. |
| مؤلفون مشاركون: | OPTIMIST-A Trial Investigators |
| المصدر: | JAMA [JAMA] 2023 Sep 19; Vol. 330 (11), pp. 1054-1063. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Pulmonary Surfactants*/administration & dosage , Pulmonary Surfactants*/therapeutic use , Respiratory Distress Syndrome, Newborn*/complications , Respiratory Distress Syndrome, Newborn*/drug therapy , Respiratory Distress Syndrome, Newborn*/therapy, Female ; Humans ; Infant ; Infant, Newborn ; Dyspnea ; Follow-Up Studies ; Infant, Premature ; Lipoproteins ; Respiratory Distress Syndrome/complications ; Respiratory Distress Syndrome/drug therapy ; Respiratory Distress Syndrome/therapy ; Respiratory Sounds ; Surface-Active Agents/administration & dosage ; Surface-Active Agents/therapeutic use ; Catheterization ; Minimally Invasive Surgical Procedures ; Continuous Positive Airway Pressure ; Male ; Child, Preschool |
| مستخلص: | Importance: 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. Objective: To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years' corrected age. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: 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. Results: 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]). Conclusions and Relevance: 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. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943. |
| التعليقات: | Comment in: JAMA. 2024 Jan 23;331(4):360-361. (PMID: 38261051) Comment in: JAMA. 2024 Jan 23;331(4):360. (PMID: 38261052) |
| فهرسة مساهمة: | Investigator: BA Darlow; M Dunn; A Salter; K Butterley; N Stephens; L Reid; R Dunn; L Stephens; T Matzolic; B Argus; E Twitchell; J Barrotta; E Noble; K Tan; E Yeomans; M Lai; P Koorts; M Broom; B Law; PY Cheung; S Van Os; C Fray; N Huneault-Purney; M Faulkner; C Horth; R Grimwood; A Riskin; T Kalinina; C Tsafrir; S Afuta; F Timstut; S Huth; F McCaffrey; H Hummler; S Gupta; M Dinan; M Casiraghi; YW Yan; KR Gopagondanahalli; S Chandran; R Dela Puerta; M Lučovnik; VL Kurtovič; AJ Olthuis; DH Baptist; HA Bouma; M Büyüktiryaki; S Sahin; B Cebeci; S Ozdemir; A Vantansever; L McKay; T McSorley; P Crowley; J Pond; C Mellish; RM Hayward; IP Morris; S Elliot; DS Patel; I Andrzejewska; A Cook; S Wolf; M Tong; R Ericksen; A Logan; P Niblack; ZR Tauscher; P Whitlow |
| المشرفين على المادة: | 0 (Lipoproteins) 0 (Pulmonary Surfactants) 0 (Surface-Active Agents) KE3U2023NP (poractant alfa) |
| تواريخ الأحداث: | Date Created: 20230911 Date Completed: 20230925 Latest Revision: 20240312 |
| رمز التحديث: | 20240312 |
| مُعرف محوري في PubMed: | PMC10495923 |
| DOI: | 10.1001/jama.2023.15694 |
| PMID: | 37695601 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2023.15694 |