Clinical trial

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

Name

IRB-P00048370

Description

Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.

Trial arms

Trial start

2024-10-01

Estimated PCD

2026-10-01

Trial end

2027-10-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Metformin

Infants in the study will receive 50% of the target dose (12.5mg/kg) for the first 6 weeks of participation. At the 6 week visit, the patient will be assessed and if found still eligible, will receive the full dose (25mg/kg) for the remaining 6 weeks of participation.

Arms:

Metformin Intervention

Size

Primary endpoint

Safety profile of kidney function

12 weeks

Safety profile of liver function

12 weeks

Recruitment feasibility

12 weeks

Eligibility criteria

Inclusion Criteria: * Infants born \> 35 weeks' gestational age AND * Received therapeutic hypothermia for clinically diagnosed HIE Exclusion Criteria: * Infants with known genetic or chromosomal disorders * Infants with a liver or kidney disease that may affect drug metabolism * Maternal metformin use while actively breastfeeding * Infant weight is below the 10th percentile (as defined by World Health Organization) at time of study drug initiation.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-05-24

1 organization

1 drug

4 indications

Organization

Boston Children's Hospital

Drug

Metformin

Indication

Hypoxic-Ischemic Encephalopathy

Indication

HIE

Indication

Neurodevelopment

Indication

Infant Development