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Can a vitamin B1 boost protect Babies' brains after severe infection?

NCT ID NCT07868679

Symptom relief Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 09, 2026 · Last updated Oct 09, 2026

Summary

Researchers are testing whether adding intravenous thiamine to standard treatment helps infants with meningitis or bacteremia develop better thinking and learning skills. The trial enrolls 240 infants up to 12 months old who show signs of these infections. Half receive thiamine once daily for three days plus standard care, and half receive a placebo plus standard care. The main goal is to compare cognitive development scores at 18 months of age.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
thiamine hydrochloride, a form of vitamin B1, given intravenously alongside standard treatment
What this could lead to
If it works, thiamine could become a low-cost addition to standard care that helps protect brain development in infants recovering from serious infections.
What could go wrong
This is a mid-stage trial, so the approach may not improve neurodevelopment. Infants in the study still receive standard care, and thiamine is generally well tolerated, but any added benefit is unproven.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

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

Up to 12 months

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≤12 months old 2. Clinical concern for bacteremia or meningitis (fever or hypothermia and lethargy; fever or hypothermia and poor feeding; fever or hypothermia and seizure, bulging fontanelle or nuchal rigidity) 3. Legal guardian has provided informed consent 4. No known neurologic or developmental comorbidity (e.g. trisomy 21, congenital structural brain abnormality) 5. Weight ≥ 2kg Exclusion Criteria: 1. Known neurologic or developmental comorbidity including genetic disorders 2. Weight \< 2 kg 3. Prior episode of bacteremia or meningitis 4. Already receiving thiamine as standard-of-care

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis meningitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacteremia Meningitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

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