Hypoglycemia and Continuous Glucose Monitoring in Neonates (Continuous Sweet Babies Study - CSBS I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Glucose profile
研究概览
简要总结
The study's main purpose is to test feasibility of Continous Glucose montoring in Neonates during the first 72 hrs.
详细描述
The overall aim of this study is to compare and evaluate the feasibility and effectiveness of CGM in clinical care of neonates and increase knowledge of hypoglycemia and neonatal glucose values.
Hypotheses: * CGM detects neonatal hypoglycemia by rapid response to changes in blood glucose levels more effectively than repeated capillary blood sampling
- CGM accurately reflects blood glucose levels within the range relevant for newborn infants. * CGM is safe and easily applied to newborn infants and allows real-time monitoring of tissue glucose levels.
Objective: Examine the feasibility of CGM-device with blood glucose assessments in neonates at risk of hypoglycemia.
• Primary outcome: Hypoglycemic episodes (glucose < 2.6 mmol/L) and rapid changes in glucose values not detected by capillary blood sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Hours 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LGA, Maternal diabetes (TID and TIID and Gestational diabetes)
排除标准
- •SGA, Prematurity, major congenital anomalies, multiple pregnancy and severe asphyxia (Apgar < 5 by 10 min. age).
研究组 & 干预措施
Neonates at risk of hypoglycemia after birth
CGM sensor placed on infant as soon as possible after birth, taken off after 72 hrs, 2 bloodspecimens drawn from babies at different timepoints to compare with CGM values. CGM used to describe glucose profile variation.
干预措施: Continous glucose monitor (Device)
结局指标
主要结局
Glucose profile
时间窗: +100hrs
CGM values by sensor compared with Realtime golden standard bloodgas glucose values.
次要结局
未报告次要终点