随机对照试验协议:与出生体重非常低的婴儿相关的结果的口腔大肠母乳剂量变化:一个随机对照试验协议
Yao Jin1,2, Zhenyan Fu3, Ji Jin3
1Nursing Department, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
BMJ open
|July 15, 2025
概括
口大乳粉 (OCA) 给药对出生时体重非常低的婴儿 (VLBWI) 显示出潜在的益处. 这项研究调查了不同剂量的OCA如何影响VLBWIs的临床结果和免疫标志物.
科学领域:
- 新生儿免疫学 新生儿免疫学
- 儿科重症监护 儿科重症监护 儿科重症监护
背景情况:
- 口大奶粉 (OCA) 给药对出生时体重非常低的婴儿 (VLBWI) 提供了免疫优势.
- 在OCA协议中存在变化,对其对血液学指数和剂量依赖影响的影响的研究有限.
- 调查剂量反应关系对于优化OCA治疗至关重要.
研究的目的:
- 为了评估口腔大肠母乳 (OCA) 剂量在非常低出生体重婴儿 (VLBWI) 中变化的疗效.
- 为了比较不同OCA治疗臂和对照组中新生儿重大并发症的发生率.
- 评估不同剂量的OCA对关键血液学和免疫学标记物的影响.
主要方法:
- 一个单中心,三臂,并行控制的随机对照试验,招收了129名VLBWI.
- 盲目的设计,随机分配参与者接受0.2毫升OCA每3或6小时10天,或标准护理.
- 主要终点包括死性肠球炎,支气管肺形和早产视网膜病变;次要终点评估免疫标记物,如IL-2,IL-4,IL-6,IL-10,TNF-α,IFN-γ和IGA.
主要成果:
- 当研究完成并可获得结果后,该部分应填写.
结论:
- 当研究完成并可获得结果后,该部分应填写.
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