Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)

Conditions

• Lumbar Puncture

Eligibility Criteria

Sex

ALL

Age

1 Day - 12 Months

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 16, 2026

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Ultrasound
  Intervention: Ultrasound of spinal canal
• No Intervention: Control Group
  Infants undergoing lumbar puncture without ultrasound assist

Primary Outcome Measure

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

Central Contacts

• Donald H Arnold, MD, MPH
  615-936-4498
  [email protected]

Locations (1)

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