THiamine for Recovery In Vulnerable Early-life Infections
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorMilton S. Hershey Medical Center
About this trial
To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≤12 months old
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)
Legal guardian has provided informed consent
No known neurologic or developmental comorbidity (e.g. trisomy 21, congenital structural brain abnormality)
Disqualifiers
Known neurologic or developmental comorbidity including genetic disorders
Weight < 2 kg
Prior episode of bacteremia or meningitis
Already receiving thiamine as standard-of-care
Trial design
Design model
Parallel
Treatments tested in this trial
thiamine hydrochloride 100 mg
DrugPatients will receive 100mg of IV thiamine in addition to standard-of-care treatment, once a day for three days
Placebo
Other interventionParticipants will receive placebo in addition to standard-of-care treatment
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: ThiamineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Neurodevelopment
The primary outcome will be cognitive neurodevelopment as measured by the Bayley Scales of Infant Development at 18 months of age. We will compare the mean cognitive score for infants who received thiamine vs. placebo in addition to standard-of-care treatment.
Time frame
The end-of-study visit will be conducted at 18 months of age for all participants. This will mean that some participants will be assessed nearly 18 months after their infection and others will be assessed ~6 months from their infection.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
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