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The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

NCT00980070 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-06-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Edward Truemper, MD · UNMC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
90 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980070 on ClinicalTrials.gov