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IV Saline for Pediatric Lumbar Puncture Success

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing a lumbar puncture as part of their clinical work-up

Ages 0 and 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 1.5 hours

Awards & highlights

Study Summary

This triallooks at if saline helps success of lumbar puncture in infants, measured by getting fluid on first try and fewer red blood cells in sample.

Who is the study for?

This trial is for infants under 3 months old who need a lumbar puncture at Children's of Alabama's Emergency Department. It's not for those with conditions like severe scoliosis, vertebral abnormalities, or those in shock needing fluid resuscitation.Check my eligibility

What is being tested?

The study tests if giving normal saline intravenous fluids before a lumbar puncture can increase the chance of getting it right on the first try without too many red blood cells in the sample.See study design

What are the potential side effects?

While receiving normal saline IV fluids is generally safe, potential side effects may include discomfort at the injection site, overhydration, or electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a lumbar puncture as part of my medical evaluation.

Select...

My child is between 0 and 3 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 1.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 1.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 1.5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Successful Lumbar Puncture

Secondary outcome measures

Cerebrospinal fluid shunts procedure

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Receives IV FluidsExperimental Treatment1 Intervention

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.

Group II: No IV FluidsActive Control1 Intervention

The control arm consists of lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,272 Total Patients Enrolled

Media Library

Normal Saline Intravenous Fluids Clinical Trial Eligibility Overview. Trial Name: NCT05302765 — N/A

Lumbar Puncture Research Study Groups: No IV Fluids, Receives IV Fluids

Lumbar Puncture Clinical Trial 2023: Normal Saline Intravenous Fluids Highlights & Side Effects. Trial Name: NCT05302765 — N/A

Normal Saline Intravenous Fluids 2023 Treatment Timeline for Medical Study. Trial Name: NCT05302765 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the prerequisites to participate in this medical research?

"This research seeks to include 190 infants with lumbar region issues. These participants must be aged between 0 and 3 months, seen at Children's of Alabama Emergency Department, and scheduled for a lumbar puncture as part of their diagnosis."

Answered by AI

Is there a recruitment period open now for this medical trial?

"As of the last update on 11/22/2022, this research is still enrolling patients. It was originally posted to clinicaltrials.gov on 11/22/2022."

Answered by AI

How many people are being monitored in this experiment?

"Indeed, according to clinicaltrials.gov this investigation is currently taking on patients. It was initially published on November 22nd 2022 and the most recent update came out around that same date. This trial expects 190 participants from a single medical centre."

Answered by AI

Is the age bracket for this clinical research restricted to those above 25 years of age?

"This clinical trial is aimed at infants aged 0 to 3 months, and it has been noted that there are 122 studies recruiting minors and 591 trials dedicated to seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

Austin Wheeler 2022. "Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05302765.