Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates

NCT04794881 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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. Clinicians often perform a repeat LP in the hope that some of the red blood cells would have cleared by then, allowing a better interpretation of the CSF findings. There is no published information whether a repeat LP provides any added information to the original traumatic LP, and if so what is the best time to repeat an LP after a traumatic LP. In this randomised controlled trial (RCT), we plan to randomly allocate neonates following a visibly traumatic LP to either undergo a repeat LP at 24 hours or 48 hours later to determine which LP gives more accurate results.

Conditions

Neonate; Meningitis; Spinal Puncture

Keywords

neonate; meningitis; lumbar puncture; traumatic

Outcome Measures

Primary Outcomes (1)

• Area under the the receiver operating characteristic (ROC) curve of uncorrected CSF WBC count in the repeat LP, with "definite or probable meningitis" taken as the reference standard.

  Primary outcome- area under the ROC curve of uncorrected CSF WBC count in the repeat LP- will be compared between the 24 hour LP and the 48 hour LP groups. The reference standard will be "definite or probable meningitis" defined as "CSF culture and/or CSF Gram stain and/or CSF Procalcitonin positive" in the baseline traumatic LP.

  Immediately after the repeat LP reports are available

Secondary Outcomes (11)

• Area under the ROC curve of corrected CSF WBC count (using 500:1 formula) in the repeat LP, with "definite or probable meningitis" taken as a reference standard

  Immediately after the repeat LP reports are available

• Area under the ROC curve of corrected CSF WBC count (using 500:1 formula) in the repeat LP, with only "definite meningitis" taken as a reference standard

  Immediately after the repeat LP reports are available

• Area under the ROC curve of corrected CSF WBC count (using 500:1 formula) in the repeat LP, with only "probable meningitis" taken as a reference standard

  Immediately after the repeat LP reports are available

• Area under the ROC curve of CSF glucose in the repeat LP, with "definite or probable meningitis" taken as a reference standard

  Immediately after the repeat LP reports are available

• Area under the ROC curve of CSF glucose in the repeat LP, with only "definite meningitis" taken as a reference standard

  Immediately after the repeat LP reports are available

Study Arms (2)

24 hours

EXPERIMENTAL

Newborn infants in this group will undergo repeat lumbar puncture at 24 hours after a traumatic lumbar puncture

Other: 24 hours

48 hours

ACTIVE COMPARATOR

Newborn infants in this group will undergo repeat lumbar puncture at 48 hours after a traumatic lumbar puncture

Other: 48 hours

Interventions

24 hours OTHER

Performing a lumbar puncture at 24 hours after a traumatic lumbar puncture

24 hours

48 hours OTHER

Performing a lumbar puncture at 48 hours after a traumatic lumbar puncture

48 hours

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Clinically too unstable to undergo the 2nd LP
• Development of fresh contraindications for performing the 2nd LP

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Sourabh Dutta

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: March 18, 2019
• Primary Completion: November 28, 2020
• Study Completion: December 1, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)