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在给极度早产新生儿注射表面活性剂之前的肺部招募:随机临床试验的2年随访

Francesca Gallini^1,2,3, Domenico Umberto De Rose⁴, Roberta Iuliano¹

¹Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

JAMA network open

|September 25, 2024

概括

在给早产婴儿注射表面活性剂之前的肺部招募,与标准护理相比,在2年后的结果中没有显著差异. 这项针对极早产婴儿的研究发现,使用输管-招募-表面活性剂-输管 (IN-REC-SUR-E) 方法没有增加风险.

科学领域:

新生儿科学新生儿科学
儿科重症监护儿科重症监护
呼吸系统医学呼吸系统医学

背景情况:

输入管-招募-表面活性剂-输出管 (IN-REC-SUR-E) 技术,涉及在施用表面活性剂之前的肺部招募,此前已被证明在提高早产婴儿治疗疗效方面是有效的.
然而,需要对神经发育,生长和呼吸系统结果的长期随访数据,以充分评估其安全性和有效性,而不是标准输管-表面活性剂-输管 (IN-SUR-E) 方法.

研究的目的:

评估使用IN-REC-SUR-E或IN-SUR-E技术治疗早产婴儿的2年随访结果.
为了比较两个治疗组在2岁的正确产后年龄 (cPNA) 中的神经发育,生长和呼吸系统的结果.

主要方法:

在35个三级新生儿重症监护室 (NICU) 进行的多中心随机临床试验 (RCT) 的婴儿后续研究.
参与者包括非常早产的婴儿 (怀孕24 0/7至27 6/7周),这些婴儿符合持续正气道压力失败标准.
婴儿被随机分配到IN-REC-SUR-E或IN-SUR-E,并以CPNA 2年评估主要结果 (死亡或严重残疾) 和次要结果 (神经发育,人体测量,呼吸道感染).

主要成果:

总共有137名婴儿在2年cPNA后进行了随访 (64名在IN-SUR-E,73名在IN-REC-SUR-E).
在2年cPNA (20.3%对13.7%,P=.36) 释放后死亡或重大残疾的主要结局中,没有观察到两组之间有显著差异.
二次结果,包括神经发育状况,人体测量测量,复发性呼吸道感染和因呼吸道原因而入院,也显示IN-REC-SUR-E和IN-SUR-E组之间没有显著差异.

结论:

两年的随访结果表明,与标准IN-SUR-E方法相比,IN-REC-SUR-E技术不会导致死亡,神经发育结果,生长或呼吸道感染的显著差异.
这些发现有助于临床医生做出有关表面活性剂施用策略的明智决定,考虑到对极度早产婴儿的长期影响.
这项研究进一步证实,在施用表面活性剂之前招募肺部是安全有效的方法,没有长期不良影响.

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