Indication for Lumbar PuncturePhase 1/2SNOWBOARDNCT00980070
The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
A Phase 1/2 study testing Pediatric Restraint for Lumbar Puncture and Lumbar Puncture Device in people with Indication for Lumbar Puncture, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Indication for Lumbar Puncture
- What is being tested?
- Pediatric Restraint for Lumbar Puncture and Lumbar Puncture Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- No indication for lumbar puncture procedure as determined by treating physician
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Childrens Hospital & Medical Center
Omaha, Nebraska, 68114
Angela Boettner, RN BSN
Edward Truemper, MD
About this study
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
- Being tested
- Pediatric Restraint for Lumbar Puncture, Lumbar Puncture Device, Standard of Care
- Keywords
- lumbar puncture positioning device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Restraint for Lumbar PunctureDevice
Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure.
Lumbar Puncture DeviceDevice
Also called Lumbar Puncture positioner
Lumbar Puncture positioner
Standard of CareOther
Lumbar Puncture positioner
| Study group | Role | What they receive |
|---|---|---|
| Positioning Device | Experimental | use of positioning device Receives: Device: Pediatric Restraint for Lumbar Puncture; Device: Lumbar Puncture Device |
| Control | Active comparator | institutional standard of care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the lumbar puncture restraint board
Measured: one time use
Secondary outcomes (1)
To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression)
Measured: One time use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Boettner, University of Nebraska
- Investigators
- Edward Truemper, MD, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980070
- Sponsor's protocol ID
- 329-09-FB
- Acronym
- SNOWBOARD
- Status last verified
- Jun 2012
- First submitted
- 17 Sep 2009
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
- ClinicalTrials.gov ID
- NCT00980070
- Acronym / sponsor ID
- SNOWBOARD / 329-09-FB
- Conditions
- Indication for Lumbar Puncture
- Keywords
- lumbar puncture positioning device
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positioning Device | Experimental | Device: Pediatric Restraint for Lumbar Puncture, Device: Lumbar Puncture Deviceuse of positioning device |
| Control | Active comparator | Other: Standard of Careinstitutional standard of care |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No indication for lumbar puncture procedure as determined by treating physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Restraint for Lumbar PunctureRestraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure. | Device | Positioning Device |
| Lumbar Puncture DeviceAlso: Lumbar Puncture positionerLumbar Puncture positioner | Device | Positioning Device |
| Standard of CareLumbar Puncture positioner | Other | Control |
Primary outcome
To evaluate the safety of the lumbar puncture restraint board
Time frame: one time use
1 secondary outcome
To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression)
Time frame: One time use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Truemper, MD principal investigator
UNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pediatric Restraint for Lumbar Puncture and Lumbar Puncture Device in people with Indication for Lumbar Puncture, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Boettner, RN, BSN (402 559-6256, aboettner@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of the lumbar puncture restraint board (time frame: one time use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.