Health Condition 1: G009- Bacterial meningitis, unspecified
Conditions
Interventions
Intervention1: 24 hour LP group: Repeat lumbar puncture (LP) will be performed at 24 hours after the original macro-traumatic LP in enrolled neonates.
Control Intervention1: 48 hour LP group: Repeat l
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. newborn infants admitted anywhere in the Neonatal unit 2. underwent lumbar puncture as part of the workup for sepsis 3. Cerebral spinal fluid visibly tinged with blood ( macro-traumatic). To ensure objectivity, 2 pediatricians must have consensus that the CSF sample is visibly tinged, when viewed in bright ambient light.
Exclusion criteria
Exclusion criteria: 1. clinically too unstable to undergo another lumbar puncture within the next 48 hours 2. lumbar puncture performed after more than 3 doses of antibiotics administered 3. CSF sample of the traumatic lumbar puncture not sent for analysis of WBC, RBC counts, glucose, protein Gram stain, culture and Procalcitonin assay 4. CSF sample appears to be purely blood as judged by a pediatrician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the ROC curve of uncorrected CSF WBC count in the repeat LP, with "definite or probable meningitis" in the original LP taken as the reference standard. Reference standard being defined as "CSF culture and/or CSF Gram stain and/or CSF Procalcitonin positive in the original traumatic LP.Timepoint: Immediately after repeat LP | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute value of corrected CSF WBC count ( using 500:1 formula) in repeat LPTimepoint: Immediately after repeat LP;Absolute value of CSF glucose in repeat LPTimepoint: Immediately after repeat LP;Absolute value of CSF protein in repeat LPTimepoint: Immediately after repeat LP;Absolute value of uncorrected CSF WBC count in repeat LPTimepoint: Immediately after repeat LP;Area under the ROC curve of corrected CSF WBC count ( using 500:1 formula) in the repeat LP, with "definite or probable meningitis" in the baseline LP taken as the reference standard.Timepoint: Immediately after repeat LP;Area under the ROC curve of corrected CSF WBC count in the repeat LP, with only "definite meningitis" in the baseline LP taken as a reference standard.Timepoint: Immediately after repeat LP.;Area under the ROC curve of corrected CSF WBC count in the repeat LP, with only "probable meningitis" in the baseline LP taken as the reference standardTimepoint: Immediately after repeat LP;Area under the ROC curve of CSF glucose in the repeat LP, with "definite or probable meningitis" in the baseline LP taken as the reference standard.Timepoint: Immediately after repeat LP;Area under the ROC curve of CSF glucose in the repeat LP, with only "definite meningitis" in the baseline LP taken as the reference standard.Timepoint: Immediately after repeat LP;Area under the ROC curve of CSF protein in the repeat LP, with "definite or probable meningitis" in the baseline LP taken as the reference standardTimepoint: Immediately after repeat LP;Area under the ROC curve of CSF protein in the repeat LP, with only "definite meningitis" in the baseline LP taken as the reference standard.Timepoint: Immediately after repeat LP;Area under the ROC curve of CSF protein in the repeat LP, with only "probable meningitis" in the baseline LP taken as the reference standard.Timepoint: Immediately after repeat LP.;Change in CSF corrected WBC count ( using 500:1 formula) from baseline traumatic LP to repeat LPTimepoint: I | — |
Countries
India
Contacts
Public ContactBhajraj Mohanandia
Postgraduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed