Clinical trials

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