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Clinical Trials/NCT07612644
NCT07612644RecruitingNot Applicable

Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)

Vanderbilt University Medical Center1 site in 1 country80 target enrollmentStarted: May 16, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
1

Study Overview

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.

Detailed Description

Lumbar puncture (LP) is a frequently performed procedure in pediatric emergency departments, most often to evaluate meningitis in hyperthermic, hypothermic, or ill-appearing neonates, infants and children. Older children often present with headaches, meningismus, and/or altered mental status.

The risks of LP include introduction of pathogens, pain, the need for multiple attempts, and failure to obtain interpretable CSF. The latter frequently leads to a spine ultrasound study the following day and, if this does not demonstrate an epidural blood clot, repeat lumbar puncture using fluoroscopic guidance by interventional radiologists.

In evaluating the management of infant sepsis, one study found that the success of the initial LP plays a significant role: infants with unsuccessful initial LPs have longer hospital stays and require more resources. Therefore, ensuring successful LPs on the first attempt is critical for minimizing healthcare utilization, optimizing patient care, and decreasing the emotional burden of this procedure on parents and patients.

Unfortunately, epidural hematoma (EDH) is not uncommon after LP, with U/S diagnosed EDH identified among 40% of patients < 6 months with a traumatic LP and among 31% of unsuccessful but nontraumatic LP's, with complete effacement of the thecal sac in 17%. The spinal canal is wide enough to accommodate EDH with only rare sequelae. However, intramedullary hemorrhage of the conus medullaris resulting in paraplegia in a neonate has been reported.

Since the introduction of the revised febrile neonate guidelines in 2021,4 the number of lumbar punctures performed in young infants has decreased substantially. A consequence of performing fewer lumbar punctures is that clinicians-particularly trainees and early-career practitioners-have fewer opportunities to maintain procedural competence. As procedural skill and confidence decline, the risk of obtaining non-interpretable or traumatic samples increases.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Day to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Donald Hayes Arnold

Professor of Pediatrics and Emergency Medicine

Vanderbilt University Medical Center

Study Sites (1)

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