Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood glucose measurement less than 2.0mmol/L
研究概览
简要总结
Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the causes of hypoglycemia in infants of diabetic mothers occurs due to a transient hyperinsulinemic state postnatally. The investigators have clinical experience and success using diazoxide in their unit for patients with hypoglycemia not adequately managed with intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study the investigators expect that by using diazoxide as the initial treatment for infants of diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the investigators will be able to decrease the number of infants requiring an intravenous by at least thirty percent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants of diabetic mothers (IDMs) or infants weighing >90%
- •Hypoglycemia: two consecutive blood glucose measurements <2.6mol/L and >1.9mmol/L in the first twelve hours of life
- •> 36 weeks gestational age
排除标准
- •Infants with symptomatic hypoglycemia (regardless of value
- •Infants who meet criteria for intravenous dextrose according to the Canadian Pediatric Society (CPS) position statement
- •Infants with contraindications for enteral feeds and/or medications
研究组 & 干预措施
Diazoxide
Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours
干预措施: Diazoxide (Drug)
Ora-plus
Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.
干预措施: Ora-plus (Drug)
结局指标
主要结局
Blood glucose measurement less than 2.0mmol/L
时间窗: 14 days
次要结局
- Number of infants with significantly low blood glucose measurements (<1.5mmol/L).(14 days)
- Length of stay for infants in hospital(14 days)
- Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L(14 days)
- Admission to neonatal intensive care unit (NICU)(14 days)
- Thrombocytopenia and/or Leukopenia(14 days)
- Electrolyte imbalance requiring clinical intervention (intravenous or oral)(14 days)