Ultrasound-Guided Lumbar Puncture to Improve CSF Yield in Infants
Official title: Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)
Run by Vanderbilt University Medical Center · NCT07612644 · Data updated 2026-11-12
A study to test whether using ultrasound during lumbar puncture in newborns and infants helps obtain usable CSF on the first try.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 12 Months |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | May 16, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07612644 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Neonates and infants under 12 months who are hemodynamically stable and require a lumbar puncture for diagnostic testing.
✕Probably not a fit
Infants older than 12 months, unstable patients, or those with known spinal anomalies or prior spinal surgery.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines ultrasound-assisted lumbar puncture in neonates and infants under 12 months to determine if a standardized ultrasound-guided approach increases the rate of CSF that can be interpreted for patient care. The procedure uses ultrasound to confirm CSF presence at L3–L5 and to guide needle insertion distance. Outcomes include CSF acquisition success and interpretability, with attention to reducing multiple attempts and hospital resource use. The trial is conducted at Vanderbilt University Medical Center and focuses on improving safety and efficiency of LPs in ill-appearing young patients. Risk considerations include potential infection, pain, and the possibility of needing repeat procedures if CSF is not interpretable.
Why it matters
Potential benefit: If successful, ultrasound-guided LP could increase first-attempt success, shorten hospital stays, and reduce parental distress.
How similar studies have gone: Prior data suggest ultrasound guidance can improve LP success in some settings, supporting further evaluation in infants.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Donald H Arnold, MD, MPH
- Email: don.arnold@vumc.org
- Phone: 615-936-4498
Similar studies
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Modified lumbar puncture procedure to reduce headaches
This study is testing a new way to do lumbar punctures to see if it can lower the chances of headaches afterwards for people who need this procedure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.