NCT00980070

The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 1 Day – 90 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Indication for Lumbar Puncture

Interventions

Type	Name	Description
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	Standard of Care	Lumbar Puncture positioner

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2009-09-18
• Last updated: 2012-06-21

Locations

1 site across 1 country: United States