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

This study is currently recruiting participants.
Verified June 2012 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Angela Boettner, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00980070
First received: September 17, 2009
Last updated: June 19, 2012
Last verified: June 2012
History of Changes

September 17, 2009
June 19, 2012
October 2009
March 2014   (final data collection date for primary outcome measure)
To evaluate the safety of the lumbar puncture restraint board [ Time Frame: one time use ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00980070 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Indication for Lumbar Puncture
  • 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 Name: Lumbar Puncture positioner
  • Other: Standard of Care
    Lumbar Puncture positioner
  • Experimental: Positioning Device
    use of positioning device
    Interventions:
    • Device: Pediatric Restraint for Lumbar Puncture
    • Device: Lumbar Puncture Device
  • Active Comparator: Control
    institutional standard of care
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
up to 90 Days
No
Contact: Angela Boettner, RN, BSN 402 559-6256 aboettner@unmc.edu
United States
 
NCT00980070
329-09-FB
No
Angela Boettner, University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Edward Truemper, MD UNMC
University of Nebraska
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP