Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

Study Overview
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Brief Summary
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The purpose of this project is to determine if administration of normal saline intravenous fluids prior to a lumbar puncture improves first time success of lumbar puncture in infants less than 3 months of age. First time success of lumbar puncture defined as cerebrospinal fluid obtained on the first attempt with less than 1000 red blood cells in the fluid specimen.

Detailed Description
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Lumbar Puncture is a common procedure performed in the Pediatric Emergency Department. This procedure is often performed to assess the cerebrospinal fluid for infection. At Children's of Alabama, approximately 75% of patients undergoing this procedure are ages 3 months of age or younger. There is hypothesis that intravenous fluid administration prior to performing a lumbar puncture in this age group will increase the chances of obtaining non-bloody spinal fluid in less attempts. A recent study by Rankin et al, infants 0 to 3 months with the diagnosis of pyloric stenosis in a pediatric emergency department were enrolled. This study measured the subarachnoid space in millimeters squared before and 1 hour after administration of normal saline intravenous fluid bolus with the use of ultrasound. The sample size was 40 patients with a mean age of 11.3 days. The study determined that fluid boluses were not associated with a significant increase in the sonographic measurement of the subarachnoid space. However, no lumbar punctures were actually performed in their study. Based on their results, they deduced that fluids may not increase lumbar puncture success rates. No studies have been published evaluating whether intravenous fluids affect the success rate of performed lumbar punctures. A prospective randomized control trial will be performed with patients of the ages 0 to 3 months. Patients to be enrolled will be all patients 3 months or less in the Children's of Alabama Pediatric Emergency Department who will be undergoing a lumbar puncture procedure as part of their clinical work-up. The control arm will have the lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure. The experimental arm will undergo normal saline intravenous fluids (20 milliliters/kilogram) prior to lumbar puncture. Bolus to be completed prior to performing the lumbar puncture in the experimental group. Providers will identify if patients in this age group are a candidate for enrollment based on inclusion and exclusion criteria. If the provider determines patient meets criteria, the provider will obtain a sealed packet that will contain a piece of paper randomizing the patient into one of the arms of the study. If the patient is assigned the experimental arm, the provider will order a normal saline intravenous fluid bolus and perform the lumbar puncture after bolus has completed. If the patient is assigned the control arm, the provider will proceed with lumbar puncture without ordering intravenous fluids. After the lumbar puncture has been completed, the provider will then fill out a brief data form that can be found within the packet. This data form will collect information that is not always documented within the electronic medical record including medical record number, arm of study (experimental vs control), training level of provider that performed each attempt, specialty of provider that performed each attempt, position of patient during each attempt, and on which attempt, if any, CSF was obtained. This form will be placed back in the packet in stored in a separate folder within a locked file cabinet. These data forms will be regularly collected. Chart review will be performed using medical record numbers from this data form to collect additional information into the de-identified excel data collection sheet. The de-identified excel data collection sheet will compile information obtained from the previously mentioned data form as well as further data collected from chart review. Data obtained from chart review will include age of patient, gender, cerebrospinal fluid appearance, number of red blood cells in cerebrospinal fluid, number of white blood cells in cerebrospinal fluid, protein count in cerebrospinal fluid, glucose in cerebrospinal fluid, and duration from completion of intravenous fluids to lumbar puncture being performed.

Official Title
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Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

Conditions
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Pediatric Lumbar Puncture

Intervention / Treatment
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* Other: Normal Saline Intravenous Fluids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 0 and 3 months Patient at Children's of Alabama's Emergency Department Undergoing a lumbar puncture as part of their clinical work-up Exclusion Criteria: Vertebral abnormalities Severe scoliosis Lumbar puncture to be performed by interventional radiology Received intravenous fluids prior to study enrollment Hypotension requiring fluid resuscitation Shock requiring fluid resuscitation Ultrasound assistance

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 3 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure. The experimental arm will undergo normal saline intravenous fluids administration (20 milliliters/kilogram) prior to lumbar puncture. Bolus to be complete prior to lumbar puncture in the experimental group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No IV Fluids<br>The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure. | |
| Experimental: Receives IV Fluids<br>The experimental arm will receive normal saline intravenous fluid administration (20 milliliters/kilogram) prior to lumbar puncture. Bolus to be complete prior to lumbar puncture in the experimental group. | Other: Normal Saline Intravenous Fluids<br>* Administration of normal saline intravenous fluids (20 milliliters/kilogram).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Lumbar Puncture | Cerebrospinal fluid obtained on first attempt with less than 1000 red blood cells in fluid. | 1 to 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successfully Obtaining Cerebrospinal Fluid | Total number of attempts to obtain cerebrospinal fluid | 1 to 1.5 hours |