Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)

NCT07612644 | Recruiting FDA Device

• 1 other identifier: IRB #251901 HELP Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Infant; Meningitis; sepsis; fever; lumbar puncture; ultrasound

Outcome Measures

Primary Outcomes (1)

• Successful LP rate

  Acquisition of CSF sufficient for cell count, culture and meningoencephalitis PCR panel (MEP).

  Time from lumbar puncture to results of CSF returned by lab, approximately 1 hour.

Secondary Outcomes (3)

• Unsuccessful ultrasound attempt

  Immediately after intervention

• Traumatic LP rate

  Time from lumbar puncture to results of CSF returned by lab, approximately 1 hour

• Number of attempts/ Number of Fluoroscopy-guided lumbar puncture (LP)

  Immediately after intervention

Study Arms (2)

Ultrasound

EXPERIMENTAL

Intervention: Ultrasound of spinal canal

Device: ultrasound contrast

Control Group

NO INTERVENTION

Infants undergoing lumbar puncture without ultrasound assist

Interventions

ultrasound contrast DEVICE

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

Ultrasound

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Meningitis; Sepsis; Fever

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Central Study Contacts

Donald H Arnold, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Emergency Medicine

Model Details: Clinical trial to determine whether ultrasound-assisted lumbar puncture in infants increases successful LP rate in comparison with lumbar puncture performed without ultrasound.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)