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Completed

NCT Number: NCT02918149

Ultrasound Assisted Lumbar Puncture in the Neonate

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.

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Key information

Conditions

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Palpation Landmark Technique

Other

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

Ultrasound-Assisted Technique LP

Device

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

Primary outcomes

  1. Proportion of Successful First Attempt LPs

    Time frame: Up to 30 minutes

    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.

Secondary outcomes

  1. Proportion of Overall Success of LPs Within 2 Attempts

    Time frame: Up to 30 minutes

    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.

  2. Difference in Length of Antibiotic Exposure

    Time frame: Length of Hospitalization (approximately 1 month)

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2016
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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