The Effectiveness of a Pediatric Lumbar Puncture Restraint Device (SNOWBOARD)

June 19, 2012 updated by: Angela Boettner, University of Nebraska
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Childrens Hospital & Medical Center
        • Contact:
          • Angela Boettner, RN BSN
        • Principal Investigator:
          • Edward Truemper, MD
        • Sub-Investigator:
          • Eric Rush, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
One time use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Edward Truemper, MD, UNMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 329-09-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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