Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorJoel Cox
About this trial
A research trial which compares standard of care against employing a novel device for immobilization of babies undergoing upright LP, the present working name for the device is LP Comfort Seat (LPCS).
The research question is:
P: In late-preterm to term babies who are 0-28 days and undergoing LP for R/O Sepsis I: Is the LPCS more effective C: Than human/RN assisted upright positioning O: In generating a higher rate of first attempt LP success
Primary outcome measure is first attempt LP success (any evidence of CSF which is diagnostically useful by content and volume)
Secondary outcome measures could include
1. A qualitatively unadulterated tap (no blood) although as you know this is hard to control even with perfect positioning and technique and single pass 2. A difference in FLACC score as measure of overall pain/comfort between test and control
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Late preterm (34 + weeks) Gestational Age to Term (42+ weeks GA)
Weight of 2.5 - 5 kg
Disqualifiers
Any contraindication to having a lumbar punture procedure
Trial design
Design model
Parallel
Treatments tested in this trial
A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS)
DeviceThe participant will be placed in the LPCS for their lumbar puncture procedure
Standard of Care (SOC)
Other interventionThe patient will be held in the upright position by a human assistant
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Lumbar Puncture Comfort Seat ArmExperimental treatment 1 intervention
Group B: Standard of Care ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
First attempt LP success
Primary outcome measure is first attempt LP success (any evidence of CSF which is diagnostically useful by content and volume)
Time frame
Assessed at each procedureSecondary outcomes
1
Clear tap
A qualitatively unadulterated tap (no blood)
Time frame
Assessed at each procedure2
FLACC Score
A difference in FLACC score as measure of overall pain/comfort between test and control
Time frame
Assessed at each procedureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joel Cox
Lead sponsor
Nova Scotia Health Authority
Sponsor institution
Nova Scotia Health Authority
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: