MedTrace Logo

Ultrasound Assisted Lumbar Puncture in the Neonate

NCT02918149 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2023-07-17

No results posted yet for this study

Summary

Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.

Conditions

  • Lumbar Puncture

Interventions

OTHER

Palpation Landmark Technique

Clinician will follow routine palpation landmark technique procedure for LP, such as identification of anatomic landmarks by palpation (i.e., superior borders of the posterior iliac crest lies in parallel with L4 spinous process). Palpation will be followed by "blind" stick of the appropriate inter-spinous process space. The study member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid.

DEVICE

Ultrasound-Assisted Technique LP

Clinician will use an ultrasound-assisted technique to perform the LP. The Phillips CX50 ultrasound machine is an FDA approved device and will be used in accordance with its approved labeling. Spinal ultrasound will be performed using a linear high-frequency transducer to locate and mark the termination of the conus medullaris, the narrowing of the spinal canal, and the midline to delineate a "safe zone". The study team member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid.

Sponsors & Collaborators

Principal Investigators

  • Jason Stoller, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02918149 on ClinicalTrials.gov