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临床试验/NCT00434772
NCT00434772已完成2 期

Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers

Shaare Zedek Medical Center2 个研究点 分布在 1 个国家开始时间: 2007年12月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
2
主要终点
glucose

研究概览

简要总结

Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth.

After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal condition, the adrenergic response seen immediately after birth suppresses insulin release and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis.

An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes after birth, followed by a spontaneous recovery before 3-4 hours of age.

In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound and sustained hypoglycemia is seen.

Early feeding is of great importance to diminish the severity and incidence of hypoglycemia. But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous infusion of glucose should be commenced. In case that IV glucose is not effective or can't be supplied immediately, intramuscular glucagon is a therapeutic alternative.

We hypothesize that a single intramuscular injection of glucagon together with the appropriate oral intake of nutrients is a safe and an effective alternative to the IV infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic mothers.

Methods Appropriately grown or large for date, term infants of insulin treated diabetic mothers, with no other known medical problems, are potential candidates for our study.

Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4 hours and then every 3 hours (before each meal) for the next 20 hours.

In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon treatment, IV glucose will immediately be instituted.

Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is achieved and the number of hospitalization days in both groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 48 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • asymptomatic hypoglycemia
  • infant of insulin treated diabetic mother
  • AGA or LGA
  • no other known medical problems

排除标准

  • concurrent medical problems
  • symptomatic hypoglycemia
  • glucose under 20 mg%

结局指标

主要结局

glucose

次要结局

  • hospitalisation days

研究者

申办方类型
Other

研究点 (2)

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