Ultrasound Assisted Lumbar Puncture in the Neonate

A Randomized Controlled Trial of Ultrasound-Assisted Versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Puncture
• Intervention / Treatment: Other: Palpation Landmark Technique; Device: Ultrasound-Assisted Technique LP

Detailed Description

Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%.

Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking.

This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method.

Primary Objective:

-To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique.

Secondary Objectives:

• To determine if bedside-ultrasound assisted LPs increases the proportion of overall successful non-traumatic LPs within 2 attempts.
• To determine if bedside-ultrasound assisted LPs is associated with a decrease in the length of antibiotic exposure in patients undergoing LPs.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Neonates and infants aged ≤6 months
2. Clinical indication for a lumbar puncture (LP), as determined by the clinical team
3. Availability of study personnel to perform bedside ultrasound

Exclusion Criteria:

1. Known spinal cord abnormality (for e.g., tethered cord, spina bifida)
2. Presence of skin and soft tissue infection at insertion site
3. Recent failed LP traumatic LP attempts within the preceding 48 hours
4. Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days
5. Clinically unstable patient, as determined by the clinical team
6. Eligible patients on the resident care team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Palpation Landmark Technique LP; Traditional landmark palpation technique will be used to perform LP	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.; Other Names: Non-Ultrasound Assisted LP
Experimental: Ultrasound-Assisted Technique LP; Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP	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.; Other Names: Phillips CX50

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of successful first attempt LPs	The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group.	Up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of overall success of LPs within 2 attempts	The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group. Providers will have 2 attempts to complete the LP. If CSF cannot be obtained within 2 attempts, any subsequent attempt will be at the discretion of the attending neonatologist and will be performed outside this study by the care team.	Up to 30 minutes
Difference in length of antibiotic exposure	To determine whether bedside-ultrasound assisted LPs are associated with a decrease in the length of antibiotic exposure in patients undergoing LPs. If LP is unsuccessful, the mean length of antibiotic exposure as compared to patients with successful LPs will be compared.	Length of Hospitalization (approximately 1 month)

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jason Stoller, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimated): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Infant; Lumbar puncture; Newborn; Ultrasonography; Cerebrospinal fluid; Spinal puncture
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 16-012757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO