Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00980070
Recruitment Status : Unknown
Verified June 2012 by Angela Boettner, University of Nebraska.
Recruitment status was:  Recruiting
First Posted : September 18, 2009
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
Angela Boettner, University of Nebraska

Tracking Information
First Submitted Date  ICMJE September 17, 2009
First Posted Date  ICMJE September 18, 2009
Last Update Posted Date June 21, 2012
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2009)
To evaluate the safety of the lumbar puncture restraint board [ Time Frame: one time use ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00980070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
Official Title  ICMJE The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Indication for Lumbar Puncture
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 17, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 90 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00980070
Other Study ID Numbers  ICMJE 329-09-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela Boettner, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Truemper, MD UNMC
PRS Account University of Nebraska
Verification Date June 2012

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