NCT06429007
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
Enrolling by Invitation
PHASE1Ages 3–6InterventionalTreatmentBoston Children's HospitalInvestigator-initiated
~30 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Metformin
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety profile of kidney function
Measured over 12 weeks
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Brian Kalish, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
\<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
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.
What this trial measures
- Safety profile of kidney function12 weeks
A renal function panel (chem 10 with renal function) will be performed prior to the initiation of therapy and at all subsequent study visits.
- Safety profile of liver function12 weeks
A liver function test (LFT) will be performed prior to the initiation of therapy and at all subsequent study visits.
- Recruitment feasibility12 weeks
To assess feasibility, the number of eligible patients will be compared to the number of patients who consent to participate in the study.