About this trial
This is a clinical trial to determine the extent to which ultrasound-assisted lumbar puncture using a standardized procedure, including use of ultrasound to ascertain the presence of cerebrospinal fluid (CSF) at L3 - L5 and the optimal needle insertion distance, increases the acquisition rate of CSF that is interpretable for patient management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Neonates and infants (< 12 months)
Hemodynamically stable
Undergoing a lumbar puncture for diagnostic testing
Disqualifiers
- Infants > 12 months and 1 day
Signs of clinical instability
Known spinal anomalies (e.g., spina bifida, meningomyelocele) or previous spinal surgery
Trial design
Parallel
Treatments tested in this trial
ultrasound contrast
DeviceUltrasound of spinal canal without contrast. We included the term "ultrasound contrast" because the choices were limited.
Treatment groups
Trial outcomes
Primary outcomes
Successful LP rate
Acquisition of CSF sufficient for cell count, culture and meningoencephalitis PCR panel (MEP).
Secondary outcomes
Unsuccessful ultrasound attempt
Ultrasound attempt in which the ultrasound operator could not complete the study and, as a result, did not attempt to use ultrasound images to inform LP. Potential causes include but are not limited to infant fussiness, inability to maintain positioning sufficient for ultrasound, and malfunction of the ultrasound machine.
Traumatic LP rate
CSF RBC count \> 500 cells/mm, the most widely accepted definition of traumatic LP. 10-12 The rate of traumatic LPs using this definition is 35 - 47% in neonates and 22 - 26% in infants (\< 13 months).
Number of attempts/ Number of Fluoroscopy-guided lumbar puncture (LP)
Number of attempts required for CSF acquisition or need for fluoroscopy-guided LP
Sponsors and contacts
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