Recruiting

Ultrasound-Assisted LBP

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07612644

Conditions

Lumbar Puncture

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

ultrasound contrast

Study Details

Brief summary:

This is a clinical trial to determine the extent to which ultrasound-assisted lumbar puncture using a standardized procedure, including use of ultrasound to ascertain the presence of cerebrospinal fluid (CSF) at L3 - L5 and the optimal needle insertion distance, increases the acquisition rate of CSF that is interpretable for patient management.

Conditions

Lumbar Puncture

Study ID

NCT07612644

Start date

May 16, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • \- Neonates and infants (< 12 months)
  • Hemodynamically stable
  • Undergoing a lumbar puncture for diagnostic testing

Exclusion Criteria:

  • \- Infants > 12 months and 1 day
  • Signs of clinical instability
  • Known spinal anomalies (e.g., spina bifida, meningomyelocele) or previous spinal surgery

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ultrasound

Intervention: Ultrasound of spinal canal

no intervention: Control Group

Infants undergoing lumbar puncture without ultrasound assist

Interventions

ultrasound contrast

Ultrasound of spinal canal without contrast. We included the term "ultrasound contrast" because the choices were limited.

Primary outcome measure

  • Successful LP rate [ Time Frame: Time from lumbar puncture to results of CSF returned by lab, approximately 1 hour. ]

Central Contacts and Locations

Central contacts

Donald H Arnold, MD, MPH

615-936-4498don.arnold@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Donald H Arnold, MD, MPH

615-936-4498don.arnold@vumc.org

don.arnold@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Infant
  • Meningitis
  • sepsis
  • fever
  • lumbar puncture
  • ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-29.