A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

March 1, 2029

Conditions
Hypoxic-Ischemic EncephalopathyHIENeurodevelopmentInfant Development
Interventions
DRUG

Metformin

"Metformin will be initiated at 25% of the target dose (4 mg/kg administered twice daily, total daily dose 8 mg/kg) for three weeks. In the absence of adverse effects, metformin dose will be escalated to 50% of the target dose (8 mg/kg administered twice daily for a total daily dose of 16mg/kg) for remaining 3 weeks to minimize potential gastrointestinal upset at higher doses. Parents will be documenting adverse events and performing glucometer checks twice a day for 3 days post dose escalation.~Parents will then receive a 6-week supply of metformin at the target dose (16 mg/kg administered twice daily, total daily dose 32 mg/kg). Adverse events will be documented and glucometer checks will be performed twice a day for 3 days following dose escalation."

Trial Locations (1)

02115

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Boston Children's Hospital

OTHER