Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants-Reference-Cited by-同舟云学术

Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants

Published:2023-09-19 Issue:11 Volume:330 Page:1054
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Dargaville Peter A.¹²,Kamlin C. Omar F.³⁴,Orsini Francesca⁵,Wang Xiaofang⁵,De Paoli Antonio G.²,Kanmaz Kutman H. Gozde⁶,Cetinkaya Merih⁷,Kornhauser-Cerar Lilijana⁸,Derrick Matthew⁹,Özkan Hilal¹⁰,Hulzebos Christian V.¹¹,Schmölzer Georg M.¹²,Aiyappan Ajit¹³,Lemyre Brigitte¹⁴,Kuo Sheree¹⁵,Rajadurai Victor S.¹⁶,O’Shea Joyce¹⁷,Biniwale Manoj¹⁸,Ramanathan Rangasamy¹⁸,Kushnir Alla¹⁹,Bader David²⁰,Thomas Mark R.²¹,Chakraborty Mallinath²²,Buksh Mariam J.²³,Bhatia Risha²⁴,Sullivan Carol L.²⁵,Shinwell Eric S.²⁶,Dyson Amanda²⁷,Barker David P.²⁸,Kugelman Amir²⁹,Donovan Tim J.³⁰,Goss Kevin C. W.³¹,Tauscher Markus K.³²,Murthy Vadivelam³³,Ali Sanoj K. M.³⁴,Clark Howard W.³⁵,Soll Roger F.³⁶,Johnson Samantha³⁷,Cheong Jeanie L. Y.³⁴³⁸,Carlin John B.⁵³⁹,Davis Peter G.³⁴,Darlow Brian A⁴⁰,Dunn Michael⁴⁰,Salter Amy⁴⁰,Butterley Karen⁴⁰,Stephens Nicky⁴⁰,Reid Lizzy⁴⁰,Dunn Ross⁴⁰,Stephens Luke⁴⁰,Matzolic Tammy⁴⁰,Argus Brenda⁴⁰,Twitchell Emily⁴⁰,Barrotta Joanna⁴⁰,Noble Elizabeth⁴⁰,Tan Kenneth⁴⁰,Yeomans Emma⁴⁰,Lai Melissa⁴⁰,Koorts Pieter⁴⁰,Broom Margaret⁴⁰,Law Brenda⁴⁰,Cheung Po-Yin⁴⁰,Van Os Sylvia⁴⁰,Fray Caroline⁴⁰,Huneault-Purney Nicole⁴⁰,Faulkner Melissa⁴⁰,Horth Chantal⁴⁰,Grimwood Rebecca⁴⁰,Riskin A⁴⁰,Kalinina Tatiana⁴⁰,Tsafrir C⁴⁰,Afuta S⁴⁰,Timstut Fanny⁴⁰,Huth Sabine⁴⁰,McCaffrey Frances⁴⁰,Hummler Helmut⁴⁰,Gupta Samir⁴⁰,Dinan Mary⁴⁰,Casiraghi Miriam⁴⁰,Yan Yip Wai⁴⁰,Gopagondanahalli Krishna R⁴⁰,Chandran Suresh⁴⁰,Dela Puerta Rowena⁴⁰,Lučovnik Miha⁴⁰,Kurtovič Vlasta L⁴⁰,Olthuis Annelies J⁴⁰,Baptist Dyvonne H⁴⁰,Bouma Helene A⁴⁰,Büyüktiryaki Mehmet⁴⁰,Sahin Suzan⁴⁰,Cebeci Burcu⁴⁰,Ozdemir Sule⁴⁰,Vantansever Aylin⁴⁰,McKay Lorna⁴⁰,McSorley Therese⁴⁰,Crowley Philippa⁴⁰,Pond Jenny⁴⁰,Mellish Christie⁴⁰,Hayward Rachel M⁴⁰,Morris Ian P⁴⁰,Elliot Sian⁴⁰,Patel Deena-Shefali⁴⁰,Andrzejewska Izabela⁴⁰,Cook Amanda⁴⁰,Wolf Sue⁴⁰,Tong Micah⁴⁰,Ericksen Rosanna⁴⁰,Logan Amanda⁴⁰,Niblack Patricia⁴⁰,Tauscher Zenaida R⁴⁰,Whitlow Pamela⁴⁰,

Affiliation:

1. Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia

2. Department of Paediatrics, Royal Hobart Hospital, Hobart, Tasmania, Australia

3. Neonatal Services, Royal Women’s Hospital, Melbourne, Victoria, Australia

4. Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia

5. Clinical Epidemiology and Biostatistics Unit, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia

6. Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey

7. Division of Neonatology, Department of Pediatrics, Istanbul Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey

8. Division of Gynaecology and Obstetrics, Department of Perinatology, University Medical Centre, Ljubljana, Slovenia

9. Division of Neonatology, Northshore University Health System, Evanston, Illinois

10. Division of Neonatology, Department of Pediatrics, Uludağ University Faculty of Medicine, Bursa, Turkey

11. Division of Neonatology, Beatrix Children’s Hospital, University Medical Center Groningen, Groningen, the Netherlands

12. Division of Neonatology, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada

13. Neonatal Services, Mercy Hospital for Women, Heidelberg, Victoria, Australia

14. Department of Obstetrics, Gynecology, and Newborn Care, The Ottawa Hospital, Ottawa, Ontario, Canada

15. Department of Pediatrics, Kapiʻolani Medical Center for Women and Children, Honolulu, Hawaiʻi

16. Department of Neonatology, KK Women’s and Children’s Hospital, Duke-NUS Medical School, Singapore

17. Neonatal Unit, Royal Hospital for Children, Glasgow, United Kingdom

18. 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

19. Department of Pediatrics, Children’s Regional Hospital, Cooper University Health Care, Camden, New Jersey

20. Rappaport Faculty of Medicine, Department of Neonatology, Bnai Zion Medical Center, Technion, Haifa, Israel

21. Department of Neonatal Medicine, Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom

22. Regional Neonatal Intensive Care Unit, University Hospital of Wales, Cardiff, United Kingdom

23. Newborn Service, Starship Child Health, Auckland Hospital, Auckland, New Zealand

24. Monash Newborn, Monash Children’s Hospital, Clayton, Victoria, Australia

25. Department of Neonatology, Singleton Hospital, Swansea, United Kingdom

26. Faculty of Medicine, Department of Neonatology, Ziv Medical Center, Bar-Ilan University, Tsfat, Israel

27. Department of Neonatology, Centenary Hospital for Women and Children, Canberra Hospital, Woden, New South Wales, Australia

28. Neonatal Intensive Care Unit, Dunedin Hospital, Dunedin, New Zealand

29. Rappaport Faculty of Medicine, Department of Neonatology, Rambam Medical Center, Technion, Haifa, Israel

30. Division of Neonatology, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia

31. Neonatal Intensive Care Unit, Princess Anne Hospital, Southampton, United Kingdom

32. Division of Neonatology, Peyton Manning Children’s Hospital, Ascension St Vincent, Indianapolis, Indiana

33. Neonatal Intensive Care Centre, The Royal London Hospital-Barts Health NHS Foundation Trust, London, United Kingdom

34. Division of Neonatology, Sidra Medicine, Doha, Qatar

35. Faculty of Population Health Sciences, Neonatology, EGA Institute for Women’s Health, University College London, London, United Kingdom

36. Division of Neonatal-Perinatal Medicine, Larner College of Medicine, The University of Vermont, Burlington

37. Infant Mortality and Morbidity Studies Research Group, Department of Population Health Sciences, University of Leicester, Leicester, United Kingdom

38. Clinical Sciences, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia

39. Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia

40. for the OPTIMIST-A Trial Investigators

Abstract

ImportanceThe 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.ObjectiveTo examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years’ corrected age.Design, Setting, and ParticipantsFollow-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.InterventionsInfants 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 MeasuresThe 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.ResultsAmong 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 RelevanceIn 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 Registrationanzctr.org.au Identifier: ACTRN12611000916943

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jama/articlepdf/2809514/jama_dargaville_2023_oi_230097_1695054973.28717.pdf

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