Diabetes drug could help Babies' brains heal after birth injury
NCT ID NCT06429007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether metformin, a common diabetes drug, is safe and feasible for infants who suffered brain injury from lack of oxygen at birth. Thirty infants under 6 months old will receive metformin for 6 weeks, with close monitoring of kidney and liver function. The goal is to see if metformin can promote brain repair and improve neurodevelopment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin
- What this could lead to
- If it works, this could point toward a treatment that helps infants recover brain function after birth injury, improving their development.
- What could go wrong
- This is a very early Phase 1 trial with only 30 infants, focused on safety and feasibility. It may not show any benefit, and metformin's effects in infants are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 6 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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