Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

NCT05302765 | Completed DMC

• 1 other identifier: UAB IRB#: IRB-300008761
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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 per mm3 in the fluid specimen.

Conditions

Pediatric Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• Successful Lumbar Puncture

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

  1 to 1.5 hours

Secondary Outcomes (3)

• Successfully Obtaining Cerebrospinal Fluid

  1 to 1.5 hours

• Time from intravenous fluid bolus completion to cerebrospinal fluid collection

  0 minutes to 1.5 hours

• Level of trainings effect on successful lumbar punctures

  1 to 1.5 hours

Study Arms (2)

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.

Other: Normal Saline Intravenous Fluids

Interventions

Normal Saline Intravenous Fluids OTHER

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

Receives IV Fluids

Eligibility Criteria

• Age: 0 Months - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 26954534 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 31, 2022
• Study Start: November 22, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)