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

Launched by BOSTON CHILDREN'S HOSPITAL · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called metformin in infants who have experienced a specific type of brain injury known as hypoxic-ischemic encephalopathy (HIE). HIE can happen when an infant's brain doesn't get enough oxygen and blood during birth, which can lead to developmental challenges. Metformin is commonly used to treat diabetes, but researchers believe it may also help the brain heal. This trial aims to see if it is safe to use metformin in young infants and if it can improve their development.

To participate in this trial, infants must be less than 6 months old and diagnosed with HIE after being born at more than 35 weeks of pregnancy. They should have received a cooling treatment called therapeutic hypothermia to help protect their brain. Families who speak English or Spanish can participate, as they will need to help monitor the child’s medication and any side effects. However, infants with certain health issues or those taking specific medications will not be eligible. This trial is not yet recruiting participants, but it offers hope for improving outcomes for infants affected by HIE.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \<6 months old at time of enrollment, and able to initiate study drug between 3 and 6 months old.
• • Born \> 35 weeks gestational age with a clinical diagnosis of HIE at birth, who receive therapeutic hypothermia.
• • Post-hypothermia brain MRI with evidence of hypoxic-ischemic brain injury, based on the neuroradiology clinical report. Specifically, participants must have had evidence of a lactate peak by magnetic resonance spectroscopy and/or signal abnormalities by conventional (T1 and/or T2) or diffusion-weighted images consistent with hypoxic-ischemic pattern of injury.
• • English- or Spanish-speaking families, as the parents/guardians will be responsible for documenting dose administrations and adverse events.
• Exclusion Criteria:
• • Known genetic or chromosomal disorder, and in the presence of congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator (PI) or delegate, affect drug metabolism.
• • Maternal use of metformin while actively breastfeeding.
• • Infant weight below the 10th percentile based on WHO growth charts at the time of study drug initiation.
• • Normal post-hypothermia brain MRI, without evidence of ischemic brain injury, based on the neuroradiology clinical report.
• • Concomitant use of the following drugs: anti-diabetic drugs (insulin, sulfonylureas), steroids, diuretics (furosemide, chlorothiazide, spironolactone), diazoxide, beta blockers, ACE inhibitors, angiotensin II blockers, calcium channel blockers (including nifedipine), phenytoin, valproic acid, topiramate, cimetidine, corticosteroids, thyroid medications, sympathomimetics, carbonic anhydrase inhibitors, or any antibiotics.
• • Any condition or diagnosis, that could in the opinion of the PI 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.