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产房德克斯特凝治疗早产低血糖症 (GEHPPI研究):一个随机的安慰剂对照试验
Graham King1,2, Julie Sloan3, Peter Duddy4
1Paediatrics and Newborn Medicine, The Coombe Hospital, Dublin, Ireland kingg1@tcd.ie.
Archives of disease in childhood. Fetal and neonatal edition
|November 8, 2024
概括
在被送往新生儿重症监护室 (NICU) 的非常早产婴儿中,口腔乳糖凝并没有减少早期低血糖症. 目前的管理策略专注于早期血管接入和静脉注射乳糖对这些脆弱的新生儿至关重要.
科学领域:
- 新生儿医学 新生儿医学
- 儿科内分泌学 儿科内分泌学
- 临床试验 临床试验
背景情况:
- 早期低血糖是进入新生儿重症监护室 (NICU) 时非常早产婴儿的常见并发症.
- 有效的干预措施,以预防早期低血糖在这个脆弱的人群中至关重要.
研究的目的:
- 为了评估在分娩室 (DR) 给药的口腔乳糖凝在减少在妊娠32周或之前出生的婴儿早期低血糖的疗效.
- 为了确定早期的糖凝应用是否会影响新生儿重症监护室入院时低血糖的发生率.
主要方法:
- 在多个新生儿单位进行了一项随机,盲目,安慰剂控制的试验.
- 妊娠年龄≤32+0周的新生儿在DR中接受了40%的乳糖凝或安慰剂凝.
- 低血糖被定义为<1.8 mmol/L,测量是在NICU入院时第一次静脉注射时.
主要成果:
- 由于招生速度缓慢,招聘工作过早停止,分析了169名婴儿的数据 (33%的目标样本大小).
- 在糖凝组 (29%) 和安慰剂组 (29%) (OR 0.95;95% CI 0.49至1.86;p=0.88) 之间没有观察到低血糖的频率有显著差异.
- 后期分析表明,如果达到目标样本大小,检测到具有统计学意义的好处的条件功率 (47%) 很低.
结论:
- 这项试验没有发现有证据表明,40%口腔德克斯特凝可以降低非常早产婴儿在NICU入院时低血糖的发生率.
- 目前的临床实践应继续优先考虑这些新生儿的迅速血管接入和早期开始静脉注射含乳糖液.
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