Metformin Treatment in Infants After Perinatal Brain Injury

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05590676
• Other study ID #: 3987
• Status: Terminated
• Phase: Phase 1
• Start date: May 2, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

HIE Patients:

1. > 35 weeks gestation at time of birth

2. =3 months at time of consent

3. Clinical diagnosis of HIE

4. Infant received therapeutic hypothermia for the treatment of HIE

5. Family lives within one hour distance of the Hospital for Sick Children (in order to facilitate home visits)

Preterm Infants:

1. <32 weeks gestation at time of birth

2. 36-44 weeks corrected (postmenstrual) gestational age at time of metformin administration

3. Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment

Exclusion Criteria:

1. Have a known genetic or chromosomal disorder.

2. Congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator or delegate, affect drug metabolism.

3. History of hypoglycemia in the newborn period requiring glucose infusion rate > 10 mg/kg/min or treatment with glucagon or diazoxide.

4. 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

5. >3 months of age at the time of enrollment (term HIE patients only)

6. Weight <10%ile based on WHO growth charts at time of initiation of study drug (term HIE patients only).

7. Maternal use of metformin while actively breastfeeding.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontartio

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	University of Alberta, University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with hypoglycemia (serum glucose <3.3mmol/L)	Number of patients with hyperglycemia (glucose>10mmol/L)	2 weeks
Secondary	Plasma metformin levels	Pharmacokinetics analysis	2 weeks
Secondary	Number of patients who complete study	Feasibility of study intervention administration	2 weeks
Secondary	Number of patients who complete all study procedures	Feasibility of executing study operations	2 weeks