The Effectiveness of a Pediatric Lumbar Puncture Restraint Device (SNOWBOARD)
This study is currently recruiting participants.
Verified June 2012 by University of Nebraska
Sponsor:
University of Nebraska
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
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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
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 May 16, 2013