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Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial

NCT06811428 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-02-06

No results posted yet for this study

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

Conditions

Interventions

DEVICE

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

OTHER

Standard of Care (SOC)

The patient will be held in the upright position by a human assistant

Sponsors & Collaborators

  • Nova Scotia Health Authority

    collaborator OTHER

  • Joel Cox

    lead OTHER

Principal Investigators

  • Joel B Cox, Medical Doctor · Nova Scotia Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-03-01
Completion
2026-04-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811428 on ClinicalTrials.gov