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