Recruiting
Phase 1
Phase 2

Lumbar Puncture

Sponsor:

University of Nebraska

Code:

NCT00980070

Conditions

Indication for Lumbar Puncture

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Pediatric Restraint for Lumbar Puncture

Lumbar Puncture Device

Standard of Care

Study Details

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.

Conditions

Indication for Lumbar Puncture

Study ID

NCT00980070

Start date

Oct, 2009

Status verified date

Jun, 2012

Completion date

Jun, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Arms

experimental: Positioning Device

use of positioning device

active comparator: Control

institutional standard of care

Interventions

Pediatric Restraint for Lumbar Puncture

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

Lumbar Puncture Device

Lumbar Puncture positioner

Standard of Care

Lumbar Puncture positioner

Primary outcome measure

  • To evaluate the safety of the lumbar puncture restraint board [ Time Frame: one time use ]

Central Contacts and Locations

Central contacts

Angela Boettner, RN, BSN

402 559-6256aboettner@unmc.edu

Locations

Childrens Hospital & Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

Principal Investigator:

Edward Truemper, MD

More Information

Sponsor

University of Nebraska

Last update posted

Jun 21, 2012

Last verified

Jun, 2012

Keywords

  • lumbar puncture positioning device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2012-06-21.