NCT01688674终止不适用
Dextrose Boluses Versus Dextrose Infusions by Burettes in Prevention of Hypoglycemia Among Preterms Admitted at Mulago Hospital: An Open Label Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence proportion of hypoglycemia
研究概览
简要总结
NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital.
ALTERNATE HYPOTHESIS
• Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in the first 72 hours of admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SELECTION CRITERIA Inclusion criteria
- •Preterms whose care givers/ mothers gave informed consent
- •Preterms whose age was < 24 hours of life
- •Preterms with birth weight ≥1kg
- •Preterms with random blood sugar ≥ 2.6 mmol/l at admission into SCU.
- •Exclusion Criteria
- •Absence of a biological mother or abandoned baby
- •Presence of gross congenital abnormalities.
- •Very sick (Apgar score ≤ 5 at 5 minutes
排除标准
- 未提供
研究组 & 干预措施
Bolus arm
Placebo Comparator
two hourly dextrose boluses administered via an intravenous cannula
干预措施: 10% dextrose (Drug)
infusion
Experimental
10% dextrose infusion by burettes
干预措施: 10% dextrose (Drug)
结局指标
主要结局
Incidence proportion of hypoglycemia
时间窗: 3months
次要结局
- survival measured as a proportion(3months)
研究者
KUTAMBA ELIZABETH
Elizabeth Kutamba.R
Makerere University
研究点 (1)
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