NCT05590676终止1 期
A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
研究概览
简要总结
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
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 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIE Patients:
- •> 35 weeks gestation at time of birth
- •≤3 months at time of consent
- •Clinical diagnosis of HIE
- •Infant received therapeutic hypothermia for the treatment of HIE
- •Family lives within one hour distance of the Hospital for Sick Children (in order to facilitate home visits)
- •Preterm Infants:
- •<32 weeks gestation at time of birth
- •36-44 weeks corrected (postmenstrual) gestational age at time of metformin administration
- •Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment
排除标准
- •Have a known genetic or chromosomal disorder.
- •Congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator or delegate, affect drug metabolism.
- •History of hypoglycemia in the newborn period requiring glucose infusion rate > 10 mg/kg/min or treatment with glucagon or diazoxide.
- •Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
- •>3 months of age at the time of enrollment (term HIE patients only)
- •Weight <10%ile based on WHO growth charts at time of initiation of study drug (term HIE patients only).
- •Maternal use of metformin while actively breastfeeding.
研究组 & 干预措施
HIE: 20 mg/kg
Experimental
干预措施: Metformin Hydrochloride (Drug)
HIE: 25 mg/kg
Experimental
干预措施: Metformin Hydrochloride (Drug)
Preterm: 15 mg/kg
Experimental
干预措施: Metformin Hydrochloride (Drug)
Preterm: 20 mg/kg
Experimental
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
时间窗: 2 weeks
Number of patients with hyperglycemia (glucose\>10mmol/L)
次要结局
- Plasma metformin levels(2 weeks)
- Number of patients who complete all study procedures(2 weeks)
- Number of patients who complete study(2 weeks)
研究者
Brian Kalish
Staff Neonatologist
The Hospital for Sick Children
研究点 (1)
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