Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hypoglycaemia whilst receiving insulin
研究概览
简要总结
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.
There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.
This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birthweight <1500g
- •Blood sugar >/= 10mmol/L
- •Clinician decision to start an insulin infusion
排除标准
- •Infants who were moribund and not expected to survive
结局指标
主要结局
Hypoglycaemia whilst receiving insulin
时间窗: Length of hospital stay in NICU which will be from birth to 5 months of age
Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.
次要结局
未报告次要终点
研究者
Adrienne Lynn
Dr Adrienne Lynn
Christchurch Women's Hospital
