The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Phase 1

• Conditions: Indication for Lumbar Puncture
• Interventions: Device: Pediatric Restraint for Lumbar Puncture; Other: Standard of Care; Device: Lumbar Puncture Device

• Registration Number: NCT00980070
• Lead Sponsor: University of Nebraska

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 available

Study Timeline

• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Study Start: 2009-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-21
• Primary Completion: 2014-03
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positioning Device	Pediatric Restraint for Lumbar Puncture	use of positioning device
Positioning Device	Lumbar Puncture Device	use of positioning device
Control	Standard of Care	institutional standard of care

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the lumbar puncture restraint board	one time use

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Childrens Hospital & Medical Center; 🇺🇸 Omaha, Nebraska, United States