U.S., Feb. 7 -- ClinicalTrials.gov registry received information related to the study (NCT06811428) titled 'Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial' on Jan. 31.
Brief 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 ...