Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05302765 |
| Other study ID # |
UAB IRB#: IRB-300008761 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2022 |
| Est. completion date |
July 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
Austin Wheeler, MD |
| Phone |
2547151357 |
| Email |
awheeler[@]uabmc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
