The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

NCT ID: NCT00980070

Last Updated: 2012-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-06-30

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.

Detailed Description

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Conditions

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Indication for Lumbar Puncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Positioning Device

use of positioning device

Group Type EXPERIMENTAL

Pediatric Restraint for Lumbar Puncture

Intervention Type DEVICE

Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure.

Lumbar Puncture Device

Intervention Type DEVICE

Lumbar Puncture positioner

Control

institutional standard of care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Lumbar Puncture positioner

Interventions

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Pediatric Restraint for Lumbar Puncture

Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure.

Intervention Type DEVICE

Lumbar Puncture Device

Lumbar Puncture positioner

Intervention Type DEVICE

Standard of Care

Lumbar Puncture positioner

Intervention Type OTHER

Other Intervention Names

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Lumbar Puncture positioner

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Angela Boettner

coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward Truemper, MD

Role: PRINCIPAL_INVESTIGATOR

UNMC

Locations

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Childrens Hospital & Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela Boettner, RN, BSN

Role: CONTACT

402 559-6256

Facility Contacts

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Angela Boettner, RN BSN

Role: primary

Other Identifiers

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329-09-FB

Identifier Type: -

Identifier Source: org_study_id

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