Status:
COMPLETED
Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Neonate
Meningitis
Eligibility:
All Genders
1-28 years
Phase:
NA
Brief Summary
Visibly traumatic as well as microtraumatic lumbar punctures (LP) are very common in the neonatal period. The presence of blood makes it difficult to interpret cerebro-spinal fluid (CSF) findings. Cli...
Detailed Description
STUDY DESIGN An open-label Randomised Control Trial, with stratification and blocking. STUDY SETTING The Newborn unit and Neonatal Unit of Pediatric Emergency of Post graduate Institute of medical edu...
Eligibility Criteria
Inclusion
- Newborn infants admitted anywhere in the Neonate unit or Neonatal Unit of Paediatric Emergency
- Underwent lumbar puncture as part of the workup for sepsis
- Cerebrospinal fluid visibly tinged with blood (macro traumatic). To ensure objectivity, two Pediatricians must have a consensus that the CSF sample is visibly blood-tinged when viewed in bright ambient light.
Exclusion
- Clinically too unstable to undergo 2 lumbar punctures within the span of 48 hours
- Lumbar puncture performed after more than 3 doses of antibiotics administered
- CSF sample of traumatic lumbar puncture not sent for analysis of WBC, RBC counts, glucose, protein, Gram stain, and culture
- Sample appears to be pure blood from the initial needle prick.
- Post-randomization exclusion
- Clinically too unstable to undergo the 2nd LP
- Development of fresh contraindications for performing the 2nd LP
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04794881
Start Date
March 18 2019
End Date
December 1 2020
Last Update
March 12 2021
Active Locations (1)
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1
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160012