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Metformin Treatment in Infants After Perinatal Brain Injury

Primary Purpose

Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth

Status

Not yet recruiting

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Metformin Hydrochloride

About this trial

This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy of Newborn focused on measuring Hypoxic Ischemic Encephalopathy, Newborn, Metformin, Prematurity

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

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)

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
>3 months of age at the time of enrollment
Weight <10%ile based on WHO growth charts at time of initiation of study drug.

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

HIE: 20 mg/kg

HIE: 25 mg/kg

Preterm: 15 mg/kg

Preterm: 20 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with hypoglycemia (serum glucose <3.3mmol/L)

Number of patients with hyperglycemia (glucose>10mmol/L)

Secondary Outcome Measures

Plasma metformin levels

Pharmacokinetics analysis

Number of patients who complete study

Feasibility of study intervention administration

Number of patients who complete all study procedures

Feasibility of executing study operations

Full Information

NCT ID

NCT05590676

First Posted

October 18, 2022

Last Updated

March 31, 2023

Sponsor

The Hospital for Sick Children

Collaborators

University of Waterloo, University of Alberta

1. Study Identification

Unique Protocol Identification Number

NCT05590676

Brief Title

Metformin Treatment in Infants After Perinatal Brain Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 10, 2023 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

Collaborators

University of Waterloo, University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth

Keywords

Hypoxic Ischemic Encephalopathy, Newborn, Metformin, Prematurity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIE: 20 mg/kg

Arm Type

Experimental

Arm Title

HIE: 25 mg/kg

Arm Type

Experimental

Arm Title

Preterm: 15 mg/kg

Arm Type

Experimental

Arm Title

Preterm: 20 mg/kg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of patients with hypoglycemia (serum glucose <3.3mmol/L)

Description

Number of patients with hyperglycemia (glucose>10mmol/L)

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Plasma metformin levels

Description

Pharmacokinetics analysis

Time Frame

2 weeks

Title

Number of patients who complete study

Description

Feasibility of study intervention administration

Time Frame

2 weeks

Title

Number of patients who complete all study procedures

Description

Feasibility of executing study operations

Time Frame

2 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIE Patients: > 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) Preterm Infants: <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 >3 months of age at the time of enrollment (term HIE patients only) Weight <10%ile based on WHO growth charts at time of initiation of study drug (term HIE patients only). Maternal use of metformin while actively breastfeeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brian T Kalish, MD

Phone

416-813-7654

Ext

301433

brian.kalish@sickkids.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Rosanna Yankanah, MSc

Phone

416-813-7654

Ext

202919

rosanna.yankanah@sickkids.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian T Kalish, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontartio

ZIP/Postal Code

M5G 1X8

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian T Kalish, MD

Phone

416-813-7654

Ext

301433

brian.kalish@sickkids.ca

12. IPD Sharing Statement

Learn more about this trial

Metformin Treatment in Infants After Perinatal Brain Injury

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