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Metformin Treatment in Infants After Perinatal Brain Injury

NCT05590676 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-03-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Waterloo

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Brian T Kalish, MD · The Hospital for Sick Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2024-02-22
Completion
2024-02-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590676 on ClinicalTrials.gov