Metformin Treatment in Infants After Perinatal Brain Injury (NCT05590676) | Clinical Trial Compass
TerminatedPhase 1
Metformin Treatment in Infants After Perinatal Brain Injury
Stopped: Low recruitment
Canada1 participantsStarted 2023-05-02
Plain-language summary
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
Who can participate
Age range3 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. \> 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)
✓. \<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
Exclusion criteria
✕. 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
What they're measuring
1
Number of patients with hypoglycemia (serum glucose <3.3mmol/L)