Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- number of hypoglycemia episodes
研究概览
简要总结
Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Hour 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight (VLBW) preterm infants (birth weight under 1500g) who were admitted before 24 hours of life in the Department of Neonatology of the University Hospital of Tours
排除标准
- •a serious congenital abnormality,
- •a skin condition that contraindicated continuous glucose monitoring,
- •a transfer toward another hospital during the first days of life
- •an absence of parental agreement.
结局指标
主要结局
number of hypoglycemia episodes
时间窗: at the end of the first 3 days of life
hypoglycemia was defined as interstitial glucose level \<50 mg/dl; consecutive or \<30 min data points \<50 mg/dl were defined as a single episode of low glucose concentration.
次要结局
- duration of hypoglycemic episodes(after their 3 first days of life)