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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 per mm3 in the fluid specimen.
Conditions:
🦠 Pediatric Lumbar Puncture
🗓️ Study Start (Actual) 22 November 2022
🗓️ Primary Completion (Estimated) 31 January 2025
✅ Study Completion (Estimated) 31 January 2025
👥 Enrollment (Estimated) 190
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

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
    • * Lumbar puncture performed or attempted at another hospital within 24 hours
Ages Eligible for Study: 0 Months to 3 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 March 2022
  • First Submitted that Met QC Criteria 29 March 2022
  • First Posted 31 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024
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