The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Indication for Lumbar Puncture

In brief

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.

Key facts

Study ID

NCT00980070

Run by

University of Nebraska

People needed

30

Starts

2009-10-01

Expected to finish

2014-06-01

Last updated by the study team

2012-06-21

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No indication for lumbar puncture procedure as determined by treating physician

Where it is running

• Childrens Hospital & Medical Center — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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