A Phase 1 interventional study of Metformin Hydrochloride in Hypoxic Ischemic Encephalopathy of Newborn and Premature Birth, sponsored by The Hospital for Sick Children. Terminated at 1 site in Canada. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by The Hospital for Sick Children · Phase 1, Interventional, and Treatment
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
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 1 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
HIE Patients:
Preterm Infants:
Exclusion Criteria:
Drug: Metformin Hydrochloride
Drug: Metformin Hydrochloride
Drug: Metformin Hydrochloride
Drug: Metformin Hydrochloride
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.
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
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children