Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Lumbar Puncture
• Intervention / Treatment: Other: Normal Saline Intravenous Fluids

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Austin Wheeler, MD; Phone Number: 2547151357; Email: awheeler@uabmc.edu
• Study Contact Backup: Name: Pallavi Ghosh, MD; Phone Number: 2054277173; Email: pghuge@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • Children's of Alabama
      • Contact: Austin Wheeler, MD; Phone Number: 205-638-6039; Email: awheeler@uabmc.edu
      • Contact: Kathy Monroe, MD; Phone Number: 2056387000; Email: krmonroe@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No IV Fluids; The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure.
Experimental: Receives IV Fluids; 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; Administration of normal saline intravenous fluids (20 milliliters/kilogram).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: UAB IRB#: IRB-300008761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No