{"id":24668,"date":"2023-10-19T04:54:00","date_gmt":"2023-10-18T20:54:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=24668"},"modified":"2023-10-19T06:09:39","modified_gmt":"2023-10-18T22:09:39","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%97%a9%e4%ba%a7%e5%84%bf%e6%8e%a5%e5%8f%97%e8%a1%a8%e9%9d%a2%e6%b4%bb%e6%80%a7%e7%89%a9%e8%b4%a8%e5%be%ae%e5%88%9b%e6%b2%bb%e7%96%97%e5%90%8e2","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=24668","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u65e9\u4ea7\u513f\u63a5\u53d7\u8868\u9762\u6d3b\u6027\u7269\u8d28\u5fae\u521b\u6cbb\u7597\u540e2\u5e74\u9884\u540e"},"content":{"rendered":"\n<p>Original Investigation&nbsp;<\/p>\n\n\n\n<p>September&nbsp;11,&nbsp;2023<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants: Follow-Up of the OPTIMIST-A Randomized Clinical Trial<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Peter A.\u00a0Dargaville,\u00a0C. Omar F.\u00a0Kamlin,\u00a0Francesca\u00a0Orsini,\u00a0et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><em>JAMA.\u00a0<\/em>Published online September 11, 2023. doi:10.1001\/jama.2023.15694<\/h3>\n\n\n\n<p><a><\/a>Key Points<\/p>\n\n\n\n<p><strong>Question<\/strong>&nbsp;&nbsp;For preterm infants with respiratory distress syndrome supported with continuous positive airway pressure (CPAP), does administration of surfactant via a thin catheter improve survival without moderate to severe neurodevelopmental disability (NDD) at 2 years of age compared with sham treatment?<\/p>\n\n\n\n<p><strong>Findings<\/strong>&nbsp;&nbsp;In this follow-up of a randomized clinical trial of 486 infants at 25 to 28 weeks\u2019 gestation, the composite outcome of death or NDD at 2 years of age occurred in 36.3% receiving minimally invasive surfactant therapy compared with 36.1% receiving sham treatment.<\/p>\n\n\n\n<p><strong>Meaning<\/strong>&nbsp;&nbsp;In preterm infants supported with CPAP, minimally invasive surfactant therapy did not lead to a reduction in the composite outcome of death or neurodevelopmental disability at 2 years of age.<a><\/a><\/p>\n\n\n\n<p>Abstract<\/p>\n\n\n\n<p><strong>Importance<\/strong>&nbsp;&nbsp;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.<\/p>\n\n\n\n<p><strong>Objective<\/strong>&nbsp;&nbsp;To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years\u2019 corrected age.<\/p>\n\n\n\n<p><strong>Design, Setting, and Participants<\/strong>&nbsp;&nbsp;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\u2019 corrected age was completed on December 9, 2022.<\/p>\n\n\n\n<p><strong>Interventions<\/strong>&nbsp;&nbsp;Infants assigned to MIST (n\u2009=\u2009242) received exogenous surfactant (200 mg\/kg poractant alfa) via a thin catheter; those assigned to the control group (n\u2009=\u2009244) received sham treatment.<\/p>\n\n\n\n<p><strong>Main Outcomes and Measures<\/strong>&nbsp;&nbsp;The key secondary outcome of death or moderate to severe NDD was assessed at 2 years\u2019 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.<\/p>\n\n\n\n<p><strong>Results<\/strong>\u00a0\u00a0Among 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, \u22127.6% 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]).<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/joi230097va_1694029694.09204.png?Expires=1697479496&amp;Signature=JpUtO6IZkZXSzVj3QYTqPrYsl0-dmYdqq86JWwVj-PqiZbw2OrMk3IKUCMf0d1lpglImUHAg~7AVlo2TPDuvCRWrMI368O3SG5Vbd8qqDOM4Vaj0klOjTTcG5I7mQKDFd~fkkZfV4JN4wYAC2fYLMllfxxf2roAKhqhB27WNZvYKQhKB~IWT7jWLdrFFHsqHMGgzPDW26~DmKaBSFqDK8ZSbk2CFNGsv1RDWjnD2DJPimipOQmlhWj6wdS81Vmf3Uan5xovBqc841QwjQXzMkPk3VPsmfN70cNP~~1yE-61sSYgV~s11sj83DcQW13YrAAtjcXE4ehWcgFGW90moBQ__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/joi230097f1_1694029694.19235.png?Expires=1697479496&amp;Signature=4tt4QvRThvH0zyjpq3ijEEYL3fX4gWtG6-nSvRGvwLKlQvON3RYkOaSmCQZx-L6nN6tZvuYicLBoNRgwGfBo38~TVJg-ci6d0BvS-FO5HYgBslnyZmI0KnFqgkEPB7ap71MOivuRds1uLvX4oLn1Su9H9hYFz6LnyChDmQU0jnc2laiJ3MItt7XkO0eH5sd4Mlx7XP3WobQHH638ITaUjyBOdwtolbxu2gtW0WfhhC61cIT7DnkNfiYS9jw82C7UXNHZ49UgEA8DJk6gKvp1oC6z361O2-3XFbkN3B7crEj1ix25BPj2LrBQhfGxTmwK7LbJLacwIvS0b8taQZIndg__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/joi230097t1_1694029694.18237.png?Expires=1697479496&amp;Signature=QZnEO0QmTmsHPE-5j95uMU8Fwcri1zbtfwGXRALz5qm7wiHFdetK3emYtsr~JfUliVAMf4ZQqYYjg7eFx~ihz1ogIpSdkOdsS1tA7xCsoNwGc05k6UmWuJiL29IQXW0F2f~6~FXkzQfwTthYPj0m8OZoYopi-j0EQFX92M0GaUjXqtlZtpK~y~GBTpOleiYBBgvb~ggvJAE4H38fBjklsXk1upcDpmJKkm4ZxTgCHhxANloTq-oIxnw8JQHJFfnng5E9Y7BG-X2gJZJv9B1ydX51JgogdI-d6kRBs1Dmjdkn3q8HX4dv2rGOS79VdTzO7kMpDGDDswGr22NQ7ByfJA__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/joi230097t2_1694029694.31965.png?Expires=1697479496&amp;Signature=bk1vvaovmTuGSVMNOUFeje~lFdF37bu~4XVQNyzM6HKKxvhyc6zGdujbsy1x4tidEbl9ONgvQLDsFbAJWHzxn-iMHPiMUYLwUu5FQKNDVYigJALLX7jovuFa-Hj~tbQe-VdOXPVKX~xxtFEz2DzO3Q7xOXTsViMV5AF7rhGOz4AbJVRJOwqGUElDqzwR9J1lEjiLmSWnHCZGriPCF5e0QBdUQ01aDtXusP9Cj0VljMtNTkyff8Ge1UhcGiVsEfzgSZ~w2WeWcSv7mcwo03Cr~qP7VIQ9BVNFL3t9EAEydYJqKYqZrOFlD5gsz6s~9dWTp7CbVnIKoZ7nf3t-j~6zjQ__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/joi230097t3_1694029694.35466.png?Expires=1697479496&amp;Signature=e5F035EcCXrVftJSYU8v8UZEfPp7gGKXWjNAdV~5XXUPQleTKXvAUdkCQ3GvWtMlyOlJdjLWzF7zsKL5qjjgF1R~enpVpWqHWMdYLk3034WRSOEhv7IKMKMfrIL~abByxUdNf04Clmp3nqNT~a58pYbNv2TBgHR7siPw5hxH4GSherMFcI4cHFiqyv9cMbizCe2t~vG6PpsQPWqq4D7TnQc0sHhZWd-NeBU15fATVk4IjiXCv86pKX57JHUNpIkseAAR0buTuQyCBrR7aWcmXsl9gALmW9dEkAop0kQdmFWkHkZR5~K2UstdL4mywkTExWy211Zy20kB9YhAxTrfqA__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/joi230097t4_1694029694.36465.png?Expires=1697479496&amp;Signature=QJICEuX2te75O9z2lLAmOMQh28JBTqTZJXUJFpwkwTRkb2kTIf07WR~05BS7smMmxx9BfUbQ2B0Wp1nyu3tzXPLkj6jqkX0tVvsXjD9Si0PFydPIWSpK0f9~D9cRcBAx94tt3w9QYSplMlF2VIzIMMw3n0AbWOLo0xVDae0McEbJt1flCvVLQnROP8RXzOBbYD7cOcJPrUdqFAmL1Ph-RuhoHWvUUCyHXuTQvuKbxAwqnnknAjOZYp1JwkAheVtRyoZdR4RnXQjb13i4pWOFMBwy~bbrphq62iIrXoHdY4jdiRRiIM1x-z3gb83qT6dsPlJPdgtC5jxWYjztDFM2eg__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<p><strong>Conclusions and Relevance<\/strong>&nbsp;&nbsp;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.<\/p>\n\n\n\n<p><strong>Trial Registration<\/strong>&nbsp;&nbsp;anzctr.org.au Identifier:&nbsp;<a href=\"https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=336668&amp;isReview=true\">ACTRN12611000916943<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Original Investigation&nbsp; September&nbsp;11,&nbsp;20 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24668"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=24668"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24668\/revisions"}],"predecessor-version":[{"id":24669,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24668\/revisions\/24669"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24668"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24668"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24668"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}