The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Overview

This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. The investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. There is no follow-up once the lumbar puncture has been completed and the data has been obtained.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Interventions

  • Device: Pediatric Restraint for Lumbar Puncture
    • Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure.
  • Device: Lumbar Puncture Device
    • Lumbar Puncture positioner
  • Other: Standard of Care
    • Lumbar Puncture positioner

Arms, Groups and Cohorts

  • Experimental: Positioning Device
    • use of positioning device
  • Active Comparator: Control
    • institutional standard of care

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the safety of the lumbar puncture restraint board
    • Time Frame: one time use

Secondary Measures

  • To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression)
    • Time Frame: One time use

Participating in This Clinical Trial

Inclusion Criteria

  • Age 1 to 90 days of life – Indication for lumbar puncture procedure as determined by the treating physician – Informed Consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis – Informed consent to enrolled in said protocol Exclusion Criteria:

  • No indication for lumbar puncture procedure as determined by treating physician

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 90 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nebraska
  • Provider of Information About this Clinical Study
    • Principal Investigator: Angela Boettner, coordinator – University of Nebraska
  • Overall Official(s)
    • Edward Truemper, MD, Principal Investigator, UNMC
  • Overall Contact(s)
    • Angela Boettner, RN, BSN, 402 559-6256, aboettner@unmc.edu

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