Bacterial meningitis (BM) Nervous System Diseases
Conditions
Interventions
Babies will be randomised 1:1 using a centralised randomisation system.
Intervention arm: Dexamethasone 0.15 mg/kg administered intravenously every 6 hours (total daily dose 0.6 mg/kg) for 4 days (16
Sponsors
City St George's, University of London
Eligibility
Sex/Gender
All
Age
0 Months to 3 Months
Inclusion criteria
Inclusion criteria: 1. Babies must fulfil one of the following age-based criteria: 1.1. Babies born at = 37+0 gestational weeks: 1.1.1. Up to and including 3 months from their birth date OR 1.2. Babies born at 34+0 to 36+6 gestational weeks: 1.2.1. Up to and including 3 months corrected age OR 1.3. Babies born less than 34+0 gestational weeks: 1.3.1. Are between 32+0 corrected gestational weeks and 3 months corrected age inclusive AND 1.3.2. Are older than 7 days of age 2. Planned or initiated treatment with antibiotics for suspected or confirmed bacterial meningitis based on having one or more of the following three clinical and/or laboratory features: 2.1. Seizures or bulging fontanelle or altered consciousness (coma) 2.2. Blood C-Reactive Protein (CRP) =20 mg/L* AND one or more of: 2.2.1. Raised cerebrospinal fluid (CSF) white cell count (>20/mm3 for neonates =28 days post birth; >5/mm3 for babies >28 days post birth)** 2.2.2. CSF protein =0.8 g/L** 2.2.3. CSF/blood glucose ratio =1000 cells/µL then CSF WBC and CSF protein should be adjusted - subtract 1 WBC per 500 RBCs - subtract 0.01 g/l protein per 1000 RBCs
Exclusion criteria
Exclusion criteria: 1. Where the randomisation cannot occur within 12 hours of the first administration of antibiotics for meningitis, or within 12 hours of the first administration of changed dose/type of antibiotics where antibiotics have been changed in dose or type for newly suspected or confirmed meningitis 2. Previous neurosurgical intervention or shunt 3. Known hypersensitivity to dexamethasone or any of its excipients 4. Previous randomisation into this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without moderate or severe neurodevelopmental impairment at 24 months of age corrected for prematurity in preterm babies, and 24 months actual age in term babies, assessed using parent-completed questionnaires with additional review of routine clinical follow-up information by a blinded endpoint review committee. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number of days spent in critical care - number of days of neonatal intensive care (defined as per national standards, indicated in the Country-specific Annex), number of days of paediatric intensive care (defined as per national standards, indicated in the Country-specific Annex (timepoint: between randomisation and hospital discharge (with an upper limit of 8 weeks from randomisation)) 2. Length of hospital stay in days (timepoint: between randomisation and hospital discharge (with an upper limit of 8 weeks from randomisation)) 3. Total number of days of antibiotic treatment for this episode of meningitis (including treatment for any relapse if applicable) (timepoint:from randomisation to termination of antibiotic treatment for meningitis (with an upper limit of 8 weeks from randomisation)) 4. Relapse of suspected or confirmed bacterial meningitis (*relapse defined as the reappearance of clinical and/or laboratory features of bacterial meningitis (as described in Section 10.1: Inclusion criteria) within 2 weeks of completing treatment for this episode (timepoint: from randomisation to termination of antibiotic treatment for meningitis (with an upper limit of 8 weeks from randomisation)) 5. Gastrointestinal haemorrhage (timepoint: between randomisation and hospital discharge or leading to re admission to hospital up to 8 weeks from randomisation) 6. Hypertension requiring drug treatment (timepoint: between randomisation and hospital discharge or leading to re-admission to hospital up to 8 weeks from randomisation) 7. Hyperglycaemia receiving insulin treatment (timepoint: between randomisation and hospital discharge or leading to re-admission to hospital up to 8 weeks from randomisation) 8. Invasive infection defined as isolation of a relevant bacterial or fungal organism from a normally sterile body fluid, such as pleural fluid, pericardial fluid, joint fluid, bone aspirate or deep tissue abscess (NOT from urine or CSF or blood) OR no isolation of a releva | — |
Countries
Canada, England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactVasha Bari
Outcome results
None listed