AzTrials
AzTrials

Pediatric Lumbar PunctureNCT05302765

Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

A study testing Normal Saline Intravenous Fluids in people with Pediatric Lumbar Puncture, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 0 to 3 months
Conditions the study is for
Pediatric Lumbar Puncture
What is being tested?
Normal Saline Intravenous Fluids
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteUnited States
Study dates
22 Nov 2022to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 3 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
  • Lumbar puncture performed or attempted at another hospital within 24 hours

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's of Alabama

    Birmingham, Alabama, 35233

Other trials in United States

About this study

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 per mm3 in the fluid specimen.

Read the 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. The bolus is to be completed prior to performing the lumbar puncture in the experimental group.

Physicians and Nurse Practitioners caring for patients who are performing a lumbar puncture as part of their clinical work-up are responsible for identifying the patient as a candidate for the study. The providers identifies if patients in the age group are a candidate for enrollment based on inclusion and exclusion criteria.

If the patient is identified to be an acceptable candidate for the study, the provider caring for the patient notifies a physician in the Emergency Department who is qualified to obtain consent for the study. Consents are available in both English and Spanish. Once consent is obtained, providers obtain a sealed packet that contains a randomized assignment into one of the arms of the study. If the patient is assigned to the experimental arm, the provider orders a 20 mL/Kg normal saline intravenous fluid bolus and performs the lumbar puncture after the bolus has completed. If the patient is assigned to the control arm, the provider proceeds with the lumbar puncture without ordering or administering intravenous fluids.

After the lumbar puncture is completed, the provider performing the lumbar puncture fills out a brief data collection form that is kept within the randomization packet. This data form collects information that is not routinely 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. These data forms are routinely collected. Chart review is performed using medical record numbers from the data collection form to collect additional information into a de-identified excel data sheet. Data obtained from chart review includes age of patient, gestational age, weight, gender, ethnicity, preferred language, duration from intravenous fluid bolus to collection of cerebrospinal fluid, cerebrospinal fluid appearance, training level of provider who performed the first attempt and final attempt, total number of attempts, position of patient during lumbar puncture, 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, additional testing, and reasoning for lumbar puncture.

Being tested
Normal Saline Intravenous Fluids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal Saline Intravenous FluidsOther

    Administration of normal saline intravenous fluids (20 milliliters/kilogram).

Study groups in NCT05302765
Study groupRoleWhat they receive
No IV FluidsNo interventionThe control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure.
Receives IV FluidsExperimentalThe 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.
Receives: Other: Normal Saline Intravenous Fluids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful Lumbar Puncture

    Cerebrospinal fluid obtained on first attempt with less than 1000 red blood cells per mm3 in fluid.

    Measured: 1 to 1.5 hours

Secondary outcomes (3)
  1. Successfully Obtaining Cerebrospinal Fluid

    Total number of attempts to obtain cerebrospinal fluid

    Measured: 1 to 1.5 hours

  2. Time from intravenous fluid bolus completion to cerebrospinal fluid collection

    Time in minutes from bolus completion to CSF collection and it's effect on success rates

    Measured: 0 minutes to 1.5 hours

  3. Level of trainings effect on successful lumbar punctures

    Outcomes sub-grouped by provider's level of training

    Measured: 1 to 1.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start22 Nov 2022
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302765
Sponsor's protocol ID
UAB IRB#: IRB-300008761
Status last verified
Jul 2025
First submitted
17 Mar 2022
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26954534

Questions about this trial

What is this clinical trial studying?

A study testing Normal Saline Intravenous Fluids in people with Pediatric Lumbar Puncture, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Lumbar Puncture (time frame: 1 to 1.5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05302765, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in