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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Nebraska.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Indication for Lumbar Puncture
Device: Pediatric Restraint for Lumbar Puncture
Device: Lumbar Puncture Device
Other: Standard of Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • To evaluate the safety of the lumbar puncture restraint board [ Time Frame: one time use ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lumbar Puncture positioner
Active Comparator: Control
institutional standard of care
Other: Standard of Care
Lumbar Puncture positioner

  Eligibility

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980070

Contacts
Contact: Angela Boettner, RN, BSN 402 559-6256 aboettner@unmc.edu

Locations
United States, Nebraska
Childrens Hospital & Medical Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Angela Boettner, RN BSN         
Principal Investigator: Edward Truemper, MD         
Sub-Investigator: Eric Rush, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Edward Truemper, MD UNMC
  More Information

No publications provided

Responsible Party: Angela Boettner, coordinator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00980070     History of Changes
Other Study ID Numbers: 329-09-FB
Study First Received: September 17, 2009
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
lumbar puncture positioning device

ClinicalTrials.gov processed this record on July 23, 2014