Bedside Ultrasound Assisted Pediatric Lumbar Puncture

Study Overview
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Brief Summary
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This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients

Detailed Description
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Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture

Official Title
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Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial

Conditions
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Infant/ Neonate Lumbar Puncture

Intervention / Treatment
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* Procedure: Ultrasound assisted lumbar puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study Exclusion Criteria: previous back surgeries parent/ guardian inability to understand informed consent parent/guardian refusal of informed consent.

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 90 days and under--Interventional<br>Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture | Procedure: Ultrasound assisted lumbar puncture<br>* 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.<br>* Other names: Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,;|
| No Intervention: 90 days and under--control<br>Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach | |
| Experimental: Over 90 days--Interventional<br>Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture | Procedure: Ultrasound assisted lumbar puncture<br>* 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.<br>* Other names: Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,;|
| No Intervention: Over 90 days--Control<br>Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traumatic lumbar puncture | RBC>10,000/ mm3 on spinal fluid analysis | 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 | average of <1hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | as reported in the subjects' medical record | average of <7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, lumbar puncture, ultrasonography, efficacy