An interventional study of Ultrasound assisted lumbar puncture in Infant/ Neonate Lumbar Puncture, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
Browse Wounds and Injuries studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
Procedure: Ultrasound assisted lumbar puncture
Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
Procedure: Ultrasound assisted lumbar puncture
Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach
An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
Also known as: Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer, or, Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
Traumatic lumbar puncture
RBC\>10,000/ mm3 on spinal fluid analysis
Time frame: up to 24 hours
Unsuccessful lumbar puncture
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
Time frame: average of <1hour
Hospital length of stay
as reported in the subjects' medical record
Time frame: average of <7days
clinical outcome/ hospital course of the patient
whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record
Time frame: 30days
number of lumbar puncture attempts
as recorded on the data collection form
Time frame: average of <1hour
time to completion of lumbar puncture
as reported in the data collection form (measured in seconds)
Time frame: average of <1hour
perception of the clinician on the usefulness of bedside ultrasound if used
as rated on a 1-5 Likert scale by the operator on the data collection form
Time frame: up to 24 hours
This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences