NCT05590676

Metformin Treatment in Infants After Perinatal Brain Injury

A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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

Conditions

• Hypoxic Ischemic Encephalopathy of Newborn
• Premature Birth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-02
• Primary completion: 2024-02-22
• Completion: 2024-02-22
• First posted: 2022-10-21
• Last updated: 2024-03-07

Locations

1 site across 1 country: Canada