NCT06811428

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 evidence of CSF which is diagnostically useful by content and volume) Secondary outcome measures could include

  1. 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. 2.A difference in FLACC score as measure of overall pain/comfort between test and control

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable sepsis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 31, 2025

Last Update Submit

January 31, 2025

Conditions

SepsisMeningitis

Keywords

Lumbar punctureSeating devicePositioning deviceNewbornNeonatalMeningitisSepsis

Outcome Measures

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)

    Assessed at each procedure

Secondary Outcomes (2)

  • Clear tap

    Assessed at each procedure

  • FLACC Score

    Assessed at each procedure

Study Arms (2)

Lumbar Puncture Comfort Seat Arm

EXPERIMENTAL

This is the group that will have the lumbar puncture conducted in an upright sitting position assisted by the medical device

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)

Standard of Care Arm

ACTIVE COMPARATOR

This is the group that will have the lumbar puncture conducted in an upright sitting position assisted by the human assistant which is present standard of care

Other: Standard of Care (SOC)

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)DEVICE

The participant will be placed in the LPCS for their lumbar puncture procedure

Lumbar Puncture Comfort Seat Arm
Standard of Care (SOC)OTHER

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

Standard of Care Arm

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Late preterm (34 + weeks) Gestational Age to Term (42+ weeks GA)
  • Weight of 2.5 - 5 kg

You may not qualify if:

  • Any contraindication to having a lumbar punture procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Marshall ASJ, Sadarangani M, Scrivens A, Williams R, Yong J, Bowler U, Linsell L, Chiocchia V, Bell JL, Stokes C, Santhanadass P, Adams E, Juszczak E, Roehr CC; 'The NeoCLEAR Collaborative Group'. Study protocol: NeoCLEAR: Neonatal Champagne Lumbar punctures Every time - An RCT: a multicentre, randomised controlled 2 x 2 factorial trial to investigate techniques to increase lumbar puncture success. BMC Pediatr. 2020 Apr 15;20(1):165. doi: 10.1186/s12887-020-02050-8.

    PMID: 32295554BACKGROUND

MeSH Terms

Conditions

SepsisMeningitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroinflammatory DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Joel B Cox, Medical Doctor

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel B Cox, Principle Investigator and Sponsor, Doctor of Medicine

CONTACT

+19029664400Joel.Cox@gatewaypaeds.ca

Amanda Latham, N/A

CONTACT

+19029664400admin@gatewaypaeds.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Joel Cox, MD, FRCPC

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share