Ultrasound Assisted Lumbar Puncture in the Neonate



Status:Recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:Any
Updated:10/11/2018
Start Date:September 2016
End Date:June 2019
Contact:Jason Stoller, MD
Email:stoller@email.chop.edu
Phone:215-590-4393

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

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.

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.

Inclusion Criteria:

1. Neonates and infants aged ≤6 months

2. Clinical indication for a lumbar puncture (LP), as determined by the clinical team

3. Availability of study personnel to perform bedside ultrasound

Exclusion Criteria:

1. Known spinal cord abnormality (for e.g., tethered cord, spina bifida)

2. Presence of skin and soft tissue infection at insertion site

3. Recent failed LP traumatic LP attempts within the preceding 48 hours

4. Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days

5. Clinically unstable patient, as determined by the clinical team

6. Eligible patients on the resident care team
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-5507
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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