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.
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.
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.
- Conditions
- Pediatric 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 group | Role | What they receive |
|---|---|---|
| No IV Fluids | No intervention | The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure. |
| Receives IV Fluids | Experimental | 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. Receives: Other: Normal Saline Intravenous Fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Successfully Obtaining Cerebrospinal Fluid
Total number of attempts to obtain cerebrospinal fluid
Measured: 1 to 1.5 hours
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
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.
- First posted31 Mar 2022
- Study start22 Nov 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Austin Wheeler, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
- ClinicalTrials.gov ID
- NCT05302765
- Acronym / sponsor ID
- UAB IRB#: IRB-300008761
- Conditions
- Pediatric Lumbar Puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| No IV Fluids | No intervention | –The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure. |
| Receives IV Fluids | Experimental | Other: Normal Saline Intravenous FluidsThe 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. |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Vertebral abnormalities
- Severe scoliosis
- Lumbar puncture to be performed by interventional radiology
- Received intravenous fluids prior to study enrollment
- Hypotension requiring fluid resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline Intravenous FluidsAdministration of normal saline intravenous fluids (20 milliliters/kilogram). | Other | Receives IV Fluids |
Primary outcome
Successful Lumbar Puncture
Time frame: 1 to 1.5 hours
Cerebrospinal fluid obtained on first attempt with less than 1000 red blood cells per mm3 in fluid.
3 secondary outcomes
Successfully Obtaining Cerebrospinal Fluid
Time frame: 1 to 1.5 hours
Time from intravenous fluid bolus completion to cerebrospinal fluid collection
Time frame: 0 minutes to 1.5 hours
Level of trainings effect on successful lumbar punctures
Time frame: 1 to 1.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 26954534Rankin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.