CompletedNot Applicable

Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

United States182 participantsStarted 2022-11-22

Plain-language 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.

Who can participate

Age range

0 Months – 3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Successful Lumbar Puncture

Timeframe: 1 to 1.5 hours

Trial details

NCT IDNCT05302765

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Pediatric Lumbar Puncture trials