Effect of IV fluids on success of lumbar puncture in infants
Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
This study is testing if giving IV fluids to infants before a lumbar puncture can help doctors get a clear sample on the first try.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 0 Months to 3 Months |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05302765 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate whether administering normal saline intravenous fluids before a lumbar puncture can improve the success rate of the procedure in infants under 3 months old. The study will involve a prospective randomized control trial at Children's of Alabama, where infants undergoing lumbar puncture will be given IV fluids to see if it increases the likelihood of obtaining clear cerebrospinal fluid on the first attempt. The primary outcome will be the success of the lumbar puncture defined by the quality of the cerebrospinal fluid collected. This research addresses a common challenge in pediatric emergency care and seeks to enhance procedural outcomes for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 0 to 3 months who are presenting to the emergency department for a lumbar puncture.
Not a fit: Patients with vertebral abnormalities, severe scoliosis, or those requiring immediate fluid resuscitation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher success rates for lumbar punctures in infants, reducing the need for multiple attempts and associated complications.
How similar studies have performed: While previous studies have explored related topics, none have specifically evaluated the impact of intravenous fluids on lumbar puncture success rates, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Austin Wheeler, MD
- Email: awheeler@uabmc.edu
- Phone: 2547151357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.