Meningitis Nervous System Diseases Meningitis due to other and unspecified causes
Conditions
Interventions
Stratified block randomisation will be used to ensure balance between the groups with respect to the collaborating hospital and corrected gestational age at trial entry.
The interventions compare:
1.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Neonates and infants in neonatal units and their maternity wards who are having a lumbar puncture 2. Parent(s) willing and able to give informed consent 3. Infants of corrected gestational age from 27+0 weeks to 44+0 weeks, AND working weight of 1,000 g or more 4. First lumbar puncture for current indication
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 24/04/2020: 1. Unable to be held in sitting position (including infants intubated and mechanically-ventilated) or other clinical condition which is likely, in the opinion of the treating clinician, to make sitting difficult, or which is likely to be compromised by sitting (e.g.open gastroschisis) 2. Previously randomised to the trial Previous exclusion criteria: 1. Unable to be held in sitting position (e.g. intubated and mechanically-ventilated) or other clinical condition which is likely to make sitting difficult, or which is likely to be compromised by sitting (e.g. open gastroschisis) 2. Previously randomised to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of infants with successful lumbar punctures, measured by whether cerebrospinal fluid is obtained and red blood cell count <10,000/mm3 on the first lumbar puncture procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/04/2020: The following short-term clinical, resource and safety outcomes have been defined as: 1. The proportion of infants with: 1.1. No cerebrospinal fluid (CSF) obtained, or pure blood/clotted, or blood-stained, or clear 1.2. CSF obtained and red blood cell (RBC) count 2 (and RBC count 500, the WBC count will be reduced by 1 for every 500 RBC counts to give a ‘corrected’ WBC count) 3.2. Equivocal: borderline white blood cell (WBC) counts, or uncertain culture result or uncertain clinical diagnosis 3.3. Negative: <20 CSF WBC count and 0–2 PMNs and negative cultures and gram stain and no clinical diagnosis of meningitis 3.4. Uninterpretable: no CSF obtained, or CSF so bloody that a cell count was impossible 4. CSF WBC, RBC, corrected WBC counts, PMNs, and lymphocytes, for any of the above 5. Time taken from start of cleaning skin to removing needle at end of all attempts 6. Infant movement assessed using a basic 4-point scale at time of procedure 7. Parental anxiety, measured using short-version STAI at baseline and within 48 hours of the first lumbar puncture procedure 8. Cost measured by assessing the duration of the antibiotic course from trial entry to discharge home 9. Cost measured by assessing the length of stay in hospital from trial entry until discharge home 10. Safety measured by assessing cardiovascular instability, including oxygen saturations and heart rate during the lumbar puncture procedure 11. Safety measured by assessing respiratory deterioration based on the requirement for escalating respiratory support within 1 hour of the lumbar puncture procedure | — |
Countries
England, United Kingdom
Outcome results
None listed