Ultrasound Assisted Lumbar Puncture in the Neonate

Study Overview
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Brief Summary
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Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.

Detailed Description
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Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a blind stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%. Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking. This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method. Primary Objective: -To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique. Secondary Objectives: To determine if bedside-ultrasound assisted LPs increases the proportion of overall successful non-traumatic LPs within 2 attempts. To determine if bedside-ultrasound assisted LPs is associated with a decrease in the length of antibiotic exposure in patients undergoing LPs.

Official Title
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A Randomized Controlled Trial of Ultrasound-Assisted Versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population

Conditions
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Lumbar Puncture

Intervention / Treatment
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* Other: Palpation Landmark Technique
* Device: Ultrasound-Assisted Technique LP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates and infants aged ≤6 months Clinical indication for a lumbar puncture (LP), as determined by the clinical team Availability of study personnel to perform bedside ultrasound Exclusion Criteria: Known spinal cord abnormality (for e.g., tethered cord, spina bifida) Presence of skin and soft tissue infection at insertion site Recent failed LP traumatic LP attempts within the preceding 48 hours Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days Clinically unstable patient, as determined by the clinical team Eligible patients on the resident care team

Ages Eligible for Study
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Maximum Age: 6 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 |
| --- | --- |
| Other: Palpation Landmark Technique LP<br>Traditional landmark palpation technique will be used to perform LP | Other: Palpation Landmark Technique<br>* Clinician will follow routine palpation landmark technique procedure for LP, such as identification of anatomic landmarks by palpation (i.e., superior borders of the posterior iliac crest lies in parallel with L4 spinous process). Palpation will be followed by blind stick of the appropriate inter-spinous process space. The study member will have 2 attempts to complete the LP. A successful attempt is obtaining cerebrospinal fluid.<br>* Other names: Non-Ultrasound Assisted LP;|
| Experimental: Ultrasound-Assisted Technique LP<br>Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP | Device: Ultrasound-Assisted Technique LP<br>* Clinician will use an ultrasound-assisted technique to perform the LP. The Phillips CX50 ultrasound machine is an FDA approved device and will be used in accordance with its approved labeling. Spinal ultrasound will be performed using a linear high-frequency transducer to locate and mark the termination of the conus medullaris, the narrowing of the spinal canal, and the midline to delineate a safe zone. The study team member will have 2 attempts to complete the LP. A successful attempt is obtaining cerebrospinal fluid.<br>* Other names: Phillips CX50;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successful first attempt LPs | The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group. | Up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of overall success of LPs within 2 attempts | The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group. Providers will have 2 attempts to complete the LP. If CSF cannot be obtained within 2 attempts, any subsequent attempt will be at the discretion of the attending neonatologist and will be performed outside this study by the care team. | Up to 30 minutes | 
| Difference in length of antibiotic exposure | To determine whether bedside-ultrasound assisted LPs are associated with a decrease in the length of antibiotic exposure in patients undergoing LPs. If LP is unsuccessful, the mean length of antibiotic exposure as compared to patients with successful LPs will be compared. | Length of Hospitalization (approximately 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Infant, Newborn, Lumbar puncture, Spinal puncture, Cerebrospinal fluid