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SNOWBOARD: The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Sponsor
University of Nebraska (Other)
Overall Status
Unknown status
CT.gov ID
NCT00980070
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
56
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pediatric Restraint for Lumbar Puncture
  • Device: Lumbar Puncture Device
  • Other: Standard of Care
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
Study Start Date :
Oct 1, 2009
Anticipated Primary Completion Date :
Mar 1, 2014
Anticipated Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Positioning Device

use of positioning device

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 Names:
  • Lumbar Puncture positioner

    		•
    Active Comparator: Control

    institutional standard of care

    Other: Standard of Care
    Lumbar Puncture positioner

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the safety of the lumbar puncture restraint board [one time use]

    Secondary Outcome Measures

    1. To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression) [One time use]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 90 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Childrens Hospital & Medical Center Omaha Nebraska United States 68114

    Sponsors and Collaborators

    • University of Nebraska

    Investigators

    • Principal Investigator: Edward Truemper, MD, UNMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Angela Boettner, coordinator, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT00980070
    Other Study ID Numbers:
    • 329-09-FB
    First Posted:
    Sep 18, 2009
    Last Update Posted:
    Jun 21, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Angela Boettner, coordinator, University of Nebraska
    lumbar puncture positioning device
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Jun 21, 2012