The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Conditions
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Indication for Lumbar Puncture

Intervention / Treatment
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* Device: Pediatric Restraint for Lumbar Puncture
* Device: Lumbar Puncture Device
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positioning Device<br>use of positioning device | Device: Pediatric Restraint for Lumbar Puncture<br>* Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure.<br>Device: Lumbar Puncture Device<br>* Lumbar Puncture positioner<br>* Other names: Lumbar Puncture positioner;|
| Active Comparator: Control<br>institutional standard of care | Other: Standard of Care<br>* Lumbar Puncture positioner<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | One time use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar puncture positioning device