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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Infants will receive 14 consecutive doses, once daily, of metformin, with two dose cohorts. Arm 1: Five infants with HIE will be enrolled on the first dose cohort of 20 mg/kg. Once complete, another five infants will be enrolled on the second dose cohort of 25 mg/kg. Arm 2: Five preterm infants will be enrolled on the first dose cohort of 15 mg/kg. Once complete, another five preterm infants will be enrolled on the second dose cohort of 20 mg/kg.
The Hospital for Sick Children
Toronto, Ontartio, Canada
Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
Number of patients with hyperglycemia (glucose\>10mmol/L)
Time frame: 2 weeks
Plasma metformin levels
Pharmacokinetics analysis
Time frame: 2 weeks
Number of patients who complete study
Feasibility of study intervention administration
Time frame: 2 weeks
Number of patients who complete all study procedures
Feasibility of executing study operations
Time frame: 2 weeks
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