eoCLEAR: optimising lumbar punctures in newborns
- Conditions
- MeningitisNervous System DiseasesMeningitis due to other and unspecified causes
- Registration Number
- ISRCTN14040914
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32295554/ protocol (added 24/04/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36460015/ (added 05/12/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38149666/ (added 28/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1082
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method
Related Research Topics
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