Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
Primary Purpose
Pediatric Lumbar Puncture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal Saline Intravenous Fluids
Sponsored by
About this trial
This is an interventional diagnostic trial for Pediatric Lumbar Puncture
Eligibility Criteria
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
Sites / Locations
- Children's of AlabamaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No IV Fluids
Receives IV Fluids
Arm 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 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.
Outcomes
Primary Outcome Measures
Successful Lumbar Puncture
Cerebrospinal fluid obtained on first attempt with less than 1000 red blood cells in fluid.
Secondary Outcome Measures
Successfully Obtaining Cerebrospinal Fluid
Total number of attempts to obtain cerebrospinal fluid
Full Information
NCT ID
NCT05302765
First Posted
March 17, 2022
Last Updated
June 19, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05302765
Brief Title
Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
Official Title
Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Lumbar Puncture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No IV Fluids
Arm Type
No Intervention
Arm Description
The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure.
Arm Title
Receives IV Fluids
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline Intravenous Fluids
Intervention Description
Administration of normal saline intravenous fluids (20 milliliters/kilogram).
Primary Outcome Measure Information:
Title
Successful Lumbar Puncture
Description
Cerebrospinal fluid obtained on first attempt with less than 1000 red blood cells in fluid.
Time Frame
1 to 1.5 hours
Secondary Outcome Measure Information:
Title
Successfully Obtaining Cerebrospinal Fluid
Description
Total number of attempts to obtain cerebrospinal fluid
Time Frame
1 to 1.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Austin Wheeler, MD
Phone
2547151357
Email
awheeler@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pallavi Ghosh, MD
Phone
2054277173
Email
pghuge@uabmc.edu
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Wheeler, MD
Phone
205-638-6039
Email
awheeler@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Kathy Monroe, MD
Phone
2056387000
Email
krmonroe@uabmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26954534
Citation
Rankin J, Wang VJ, Goodarzian F, Lai HA. Intravenous Fluid Bolus Prior to Neonatal and Infant Lumbar Puncture: A Sonographic Assessment of the Subarachnoid Space After Intravenous Fluid Administration. JAMA Pediatr. 2016 Mar;170(3):e154636. doi: 10.1001/jamapediatrics.2015.4636. Epub 2016 Mar 7.
Results Reference
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Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
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