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

NCT04794881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-03-12

No results posted yet for this study

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

Interventions

OTHER

24 hours

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

OTHER

48 hours

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Sourabh Dutta · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2020-11-28
Completion
2020-12-01

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794881 on ClinicalTrials.gov