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临床试验/NCT01419873
NCT01419873已完成4 期

Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Christchurch Women's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年8月1日最近更新:
适应症
相关药物

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

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

发起方
Christchurch Women's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrienne Lynn

Dr Adrienne Lynn

Christchurch Women's Hospital

研究点 (1)

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