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Not Yet Recruiting NCT07868679

THiamine for Recovery In Vulnerable Early-life Infections

Conditions: Meningitis, Bacteremia

Sex: All
Ages: N/A – 12 Months
Healthy volunteers: No
Phase: PHASE2
Enrollment: 240
Sponsor: Milton S. Hershey Medical Center

Location: Boston Children's Hospital Boston Massachusetts

Summary

To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07868679). StuddyBuddy aggregates publicly available trial information.