Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-08-31
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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90 days and under--Interventional
Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
Ultrasound assisted lumbar puncture
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.
90 days and under--control
Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
No interventions assigned to this group
Over 90 days--Interventional
Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
Ultrasound assisted lumbar puncture
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.
Over 90 days--Control
Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach
No interventions assigned to this group
Interventions
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Ultrasound assisted lumbar puncture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* parent/ guardian inability to understand informed consent
* parent/guardian refusal of informed consent.
12 Months
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Samuel Lam, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Countries
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Other Identifiers
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AHC 4746
Identifier Type: -
Identifier Source: org_study_id
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