严重急性营养不良儿童胃肠炎补水 (GASTROSAM):第二阶段随机对照试验:试验协议
Peter Olupot-Olupot1,2, Florence Aloroker3, Ayub Mpoya4
1Department of Paediatrics, Mbale Clinical Research Institute, Pallisa Road, Mbale, PO Box 291, Uganda.
Wellcome open research
|January 18, 2024
概括
自由的补水策略可以改善严重急性营养不良 (SAM) 和腹的儿童的结果. GASTROSAM试验正在测试这些方法是否能减少住院儿童的死亡率和不良事件.
科学领域:
- 儿科胃肠病学 儿科胃肠病学
- 传染性疾病 传染性疾病
- 全球健康 全球健康
背景情况:
- 儿童严重急性营养不良 (SAM) 经常因腹而复杂,导致结果不佳.
- 目前对SAM的补水指南是保守的,使用低溶液和限制静脉注射液体,导致高死亡率.
- 现有的基于专家意见的关于SAM儿童腹流体和电解质管理的指南存在争议.
研究的目的:
- 重新评估当前对SAM和腹儿童的补水建议,以死亡率为主要结局.
- 调查是否自由的补水策略,无论是静脉注射还是口服,都可以减少这种脆弱人群的不良结果.
- 在中度到严重脱水的儿童中,比较世卫组织标准口服补水盐 (ORS) 与低ReSoMal的安全性和有效性.
主要方法:
- 在乌干达,肯尼亚,尼日利亚和尼日尔进行的部分因子设计的开放式II期试验.
- 招募6个月至12岁的儿童患有SAM,胃肠炎和中度至重度脱水.
- 分层随机化:分层A (严重脱水) 与世卫组织C计划,缓慢补水和世卫组织SAM疗法相比较;分层B (中度脱水和IV后) 与标准世卫组织ORS和ReSoMal相比较.
主要成果:
- 静脉注射补水的主要结局:死亡率为96小时.
- 口服补水的主要结局:随机化后24小时水平的变化.
- 二级结局包括安全性评估,如肺和心力衰竭,电解质平衡和水平的变化.
结论:
- 该GASTROSAM试验旨在提供基于证据的建议,用于SAM的补水.
- 积极的发现可能会导致儿童营养不良和腹的当前治疗指南的修订.
- 结果可能会为未来的大规模III期试验提供信息,以进一步验证自由化补水策略.
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