IV Saline for Pediatric Lumbar Puncture Success

Overseen By Kathy Monroe, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Vertebral abnormalities, Severe scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether administering normal saline (a type of saltwater) through an IV before a spinal tap can increase the likelihood of a successful procedure in infants under three months old. A successful spinal tap involves obtaining a clean sample of spinal fluid on the first attempt. The trial includes two groups: one receiving the saline IV and the other not. It seeks infants who are patients at the Children's of Alabama's Emergency Department and are already scheduled for a spinal tap as part of their care. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance medical procedures for infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that normal saline intravenous fluids are safe for infants?

Research has shown that normal saline IV fluids are safe and well-tolerated. Hospitals often use this solution to maintain normal sodium levels in the blood, especially in children. The FDA has approved normal saline for various medical uses, including blood transfusions, due to its safety profile. Rare side effects may occur, such as fever, infection at the injection site, or blood clotting near the injection area, but these are uncommon and usually not serious. Overall, normal saline is trusted and widely used in medical settings for its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intravenous saline before pediatric lumbar punctures because it could enhance the success rate of these procedures. Unlike the standard approach, which often skips pre-procedure hydration, this method involves administering a saline solution to potentially make the procedure easier and more effective. By optimizing the conditions for the lumbar puncture, this approach might reduce the number of attempts needed, leading to a smoother experience for young patients.

What evidence suggests that normal saline intravenous fluids might be an effective treatment for improving first-time success of lumbar puncture in infants?

Research shows that normal saline IV fluids often help maintain hydration and the body's salt balance. Although these fluids are safe and widely used for various medical purposes, limited research exists on their impact on the success of lumbar punctures in infants. In this trial, one group will receive normal saline intravenous fluids before the lumbar puncture to test this hypothesis. Some studies suggest these fluids might not significantly increase success rates. The hypothesis is that better hydration could facilitate a successful lumbar puncture on the first attempt, but more evidence is needed to confirm this in infants. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My child is between 0 and 3 months old.

Patient at Children's of Alabama's Emergency Department

Exclusion Criteria

My lumbar puncture will be done by a radiology specialist.

I needed fluids given quickly due to a severe drop in blood pressure.

I have abnormalities in my spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo lumbar puncture with or without prior administration of intravenous fluids

1 day

1 visit (in-person)

Follow-up

Participants are monitored for success of lumbar puncture and any immediate post-procedure effects

1.5 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Normal Saline Intravenous Fluids

Trial Overview 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.

How Is the Trial Designed?

Group I: Receives IV Fluids Experimental Treatment 1 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 Fluids Active Control 1 Intervention

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

Normal Saline Intravenous Fluids is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Normal Saline IV Fluids for:

• Rehydration
• Fluid replacement
• Electrolyte imbalance correction

Approved in United States as Normal Saline IV Fluids for:

• Rehydration
• Fluid replacement
• Electrolyte imbalance correction

Approved in Canada as Normal Saline IV Fluids for:

• Rehydration
• Fluid replacement
• Electrolyte imbalance correction

Approved in Japan as Normal Saline IV Fluids for:

• Rehydration
• Fluid replacement
• Electrolyte imbalance correction

Approved in China as Normal Saline IV Fluids for:

• Rehydration
• Fluid replacement
• Electrolyte imbalance correction

Approved in Switzerland as Normal Saline IV Fluids for:

• Rehydration
• Fluid replacement
• Electrolyte imbalance correction

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a study of 706 administrations of 3% sodium chloride through peripheral venous catheters, 10.5% were associated with infusion-related adverse events (IRAE), primarily mild cases of infiltration or phlebitis.

The risk of IRAE increased with the duration of the infusion, suggesting that short-term peripheral administration of 3% sodium chloride may be safe in acute care settings, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of peripherally administered 3% hypertonic saline. Deveau, RF., Marino, KK., Crowley, KE., et al.[2023]

The standard use of hypotonic fluids (0.2-0.45% NaCl) for rehydrating children with gastroenteritis has been linked to a high incidence of hospital-acquired hyponatremia (18.5%), which can lead to serious complications like hyponatremic encephalopathy.

A safer and more effective alternative is to use a continuous infusion of 0.9% NaCl after an initial bolus, as it prevents hyponatremia and more effectively corrects volume deficits in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving intravenous fluid therapy in children with gastroenteritis. Moritz, ML., Ayus, JC.[2021]

Acute hyponatremia with cerebral edema in hospitalized children has been linked to the use of hypotonic saline IV fluids, prompting a need for improved prescribing practices.

The implementation of a clinical practice guideline (CPG) at The Hospital for Sick Children successfully reduced the use of hypotonic IV solutions, demonstrating the effectiveness of structured safety initiatives in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with a pediatric clinical practice guideline for intravenous fluid and electrolyte administration. Hurdowar, A., Urmson, L., Bohn, D., et al.[2019]

In a study involving 106 critically injured patients, the rapid infusion of hypertonic solutions (7.5% sodium chloride and 7.5% sodium chloride with 6% dextran 70) showed a favorable safety profile, with no significant adverse effects like central pontine myelinolysis or anaphylactoid reactions.

While eight patients experienced hyperchloremic acidemia, they were already in critical condition, suggesting that the hypertonic solutions did not significantly worsen their status, indicating a favorable risk-to-benefit ratio for these treatments in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of potential risks associated with 7.5% sodium chloride resuscitation of traumatic shock. Vassar, MJ., Perry, CA., Holcroft, JW.[2022]

A survey of 472 pediatric residents revealed that 78% would choose hypotonic maintenance intravenous fluids (mIVF) for children with arginine vasopressin (AVP) excess, indicating a common preference for these fluids in clinical practice.

Isotonic mIVF were more frequently selected for older children and those with meningitis, suggesting that clinical scenarios significantly influence fluid choice among pediatric residents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance intravenous fluid prescribing practices among paediatric residents. Freeman, MA., Ayus, JC., Moritz, ML.[2021]

In a study of 124 postoperative children, the use of isotonic saline (0.9% NS) significantly reduced the risk of hyponatremia compared to hypotonic saline (0.45% N/2), with hyponatremia occurring in 30% of the N/2 group versus 10% in the NS group after 8 hours.

The type of intravenous fluid administered was more critical in determining the risk of hyponatremia than the rate of administration, highlighting the importance of fluid choice in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. Neville, KA., Sandeman, DJ., Rubinstein, A., et al.[2015]

Over a 10-year study involving 2,306 patients across a large healthcare system, there were no reported local infusion reactions associated with the administration of 3% sodium chloride (NaCl), indicating its safety for use through peripheral IVs.

The findings suggest that 3% NaCl can be safely administered for treating conditions like hyponatremic encephalopathy without the risk of local infusion complications, which may encourage its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of 3% Sodium Chloride and Local Infusion Reactions. Moritz, ML., Ayus, JC., Nelson, JB.[2022]

In a study of 289 nulliparous women in active labor, the use of intravenous dextrose solutions (5% or 10%) significantly shortened the second stage and total length of labor compared to normal saline alone.

There were no significant differences in cesarean section rates or maternal and neonatal outcomes among the different treatment groups, suggesting that dextrose solutions are safe and effective for improving labor duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blinded, controlled trial comparing parenteral normal saline with and without dextrose on the course of labor in nulliparas. Shrivastava, VK., Garite, TJ., Jenkins, SM., et al.[2022]

This study aims to compare the incidence of hyperchloremia in critically ill children receiving different intravenous fluids, specifically 0.9% sodium chloride versus balanced solutions like Plasma-Lyte 148 and Compound Sodium Lactate, with a target enrollment of 480 patients.

The primary outcome is to measure the increase in serum chloride levels within 48 hours, which will help determine if balanced solutions can reduce the risk of adverse outcomes associated with traditional saline therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU-a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial. Raman, S., Schibler, A., Marsney, RL., et al.[2021]

The study evaluated the safety and efficacy of a hypotonic 0.225% sodium chloride infusion in 20 critically ill patients with hypernatremia, showing a significant decrease in serum sodium levels from 156 to 143 mEq/L over 3-7 days (P < .001).

While the infusion effectively lowered sodium levels, it also indicated potential minor hemolysis, as evidenced by an increase in plasma free hemoglobin, suggesting that further research is needed to confirm the safety of this treatment before it can be routinely recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous hypotonic 0.225% sodium chloride infusion for the treatment of hypernatremia in critically ill patients. Dickerson, RN., Maish, GO., Weinberg, JA., et al.[2015]

In a study involving 150 hospitalized children, both normal saline and N/2 saline were found to have a low and comparable incidence of hyponatremia during the first 48 hours of treatment, indicating that either fluid can be safely used for maintenance.

At 24 hours, the mean serum sodium levels were slightly higher in the normal saline group compared to the N/2 saline group, suggesting that normal saline may provide a marginally better sodium balance in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial. Bagri, NK., Saurabh, VK., Basu, S., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-pediatric-lumbar-puncture-6-2022-736d0

IV Saline for Pediatric Lumbar Puncture Success 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05302765

Intravenous Fluid Administration's Effect on Pediatric ... Based on their results, they deduced that fluids may not increase lumbar puncture success rates. No studies have been published evaluating whether intravenous ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545210/

Normal Saline - StatPearls - NCBI Bookshelf Normal saline is used to treat both adult and pediatric populations as a source of hydration and electrolyte disturbances.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8908795/

Fluid Resuscitation in Children—Better to be “Normal” or “ ... ... with balanced/buffered fluids can safely improve outcomes compared to 0.9% saline. After all, with nearly 200 years of fluid administration, an answer is due.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05717-4

PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid ... PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8240589/

Safety and Success of Lumbar Puncture in Young Infants Conclusions: LP was safe in most infants. Body weight or GA at LP did not affect LP failure. These data are useful to clinicians, providing information on the ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S1473050218300557

0.9% NaCl (Normal Saline) The FDA considers both normal saline and Plasma-Lyte A equally effective and safe for administration and dilution of transfused blood components according to ...