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Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial
Sponsor: Joel Cox
Summary
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
Key Details
Gender
All
Age Range
0 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2025-03-01
Completion Date
2026-04-01
Last Updated
2025-02-06
Healthy Volunteers
No
Conditions
Interventions
A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS)
The participant will be placed in the LPCS for their lumbar puncture procedure
Standard of Care (SOC)
The patient will be held in the upright position by a human assistant