The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00980070

Acronym

SNOWBOARD

Enrollment

Registered

2009-09-18

Start date

2009-10-31

Completion date

2014-06-30

Last updated

2012-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indication for Lumbar Puncture

Keywords

lumbar puncture positioning device

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.

Interventions

DEVICEPediatric Restraint for Lumbar Puncture

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

DEVICELumbar Puncture Device

Lumbar Puncture positioner

OTHERStandard of Care

Lumbar Puncture positioner

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 90 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of the lumbar puncture restraint board	one time use

Secondary

Measure	Time frame
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

Countries

United States

Contacts

Primary ContactAngela Boettner, RN, BSN

aboettner@unmc.edu402 559-6256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026