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PI has relocated to another institution, no other site PI to take over
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90 days and under--Interventional | Experimental | Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture |
|
| 90 days and under--control | No Intervention | Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach | |
| Over 90 days--Interventional | Experimental | Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture |
|
| Over 90 days--Control | No Intervention | Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound assisted lumbar puncture | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | as reported in the subjects' medical record | average of <7days |
| Measure | Description | Time Frame |
|---|---|---|
| clinical outcome/ hospital course of the patient | whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record | 30days |
| number of lumbar puncture attempts |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Lam, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
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as recorded on the data collection form
| average of <1hour |
| time to completion of lumbar puncture | as reported in the data collection form (measured in seconds) | 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 | up to 24 hours |