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一个多中心的新生儿干预随机对照试验雾化表面活性剂的早产婴儿有呼吸困扰:Neo-INSPIRe试验协议
Ilse Lategan1, David Durand2, Michael Harrison1,3
1Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
BMC pediatrics
|September 19, 2023
概括
这项研究研究了气溶表面活性剂的早产婴儿呼吸困扰综合征,旨在减少侵入性表面活性剂治疗的需要. 结果将为新生儿提供少入侵的呼吸辅助策略.
科学领域:
- 新生儿医学 新生儿医学
- 呼吸系统生理学 呼吸系统生理学
- 临床试验 临床试验
背景情况:
- 呼吸困扰综合征 (RDS) 是早产婴儿死亡的主要原因之一.
- 包括持续正气道压力 (CPAP) 在内的较少侵入性表面活性剂施用方法改善了结果.
- 雾化表面活性剂提供了一个非侵入性的替代品,在资源有限的环境中尤其有价值.
研究的目的:
- 评估一种新型气溶表面活性剂药物/设备组合在早产婴儿中的疗效和安全性.
- 要确定与单独CPAP相比,气溶液表面活性剂是否减少了内内表面活性剂灌注的需要.
- 评估二次结局,包括呼吸支持续时间和支气管肺功能障碍.
主要方法:
- 新INSPIRe试验是一个无盲目的,多中心的,随机的试验.
- 纳入标准:早产婴儿 (27-34周GA,900-1999g) 需要CPAP与FiO2 0.25-0.35在2-24小时内.
- 婴儿1:1随机分配给单独CPAP (对照组) 或CPAP与气溶表面活性剂 (干预组).
主要成果:
- 主要结局是需要在72小时内内内玻尿酸表面活性剂.
- 其次性结局包括呼吸支功能衰竭,通风持续时间和支气管肺功能失调.
- 这项研究有能力检测出40%的相对风险降低,需要内表面活性剂.
结论:
- 喷雾式表面活性剂为早产婴儿的RDS管理提供了一种有希望的,不那么侵入性的方法.
- 新INSPIRe试验将提供关键证据,证明这种新型输送方法的有效性.
- 这些发现可能会对新生儿呼吸系统护理产生重大影响,尤其是在资源有限的地区.
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