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

190 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Normal Saline Intravenous Fluids for pediatric lumbar puncture success?

Research shows that using normal saline as an intravenous fluid can help prevent hyponatremia (low sodium levels in the blood) in hospitalized children, which is important for maintaining proper fluid balance and potentially improving overall treatment outcomes. ^{1 2 3 4 5}

Is 0.9% sodium chloride solution safe for use in humans?

0.9% sodium chloride solution, also known as normal saline, is commonly used in medical settings. However, it has been associated with increased levels of chloride in the blood, which can lead to worse outcomes in critically ill patients, such as metabolic acidosis (a condition where the body produces too much acid or the kidneys do not remove enough acid). ^{4 6 7 8 9}

How does the treatment of Normal Saline IV Fluids differ from other treatments for pediatric lumbar puncture success?

Normal Saline IV Fluids (0.9% Sodium Chloride Solution) are unique because they provide isotonic hydration, which helps maintain normal sodium levels and reduces the risk of hyponatremia (low sodium levels) compared to hypotonic solutions. This is important in preventing complications like cerebral edema (brain swelling) in children, which can occur with other fluid types. ^{3 5 7 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial. [2020]

2. United States 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. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Compliance with a pediatric clinical practice guideline for intravenous fluid and electrolyte administration. [2019]

4. United States 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. [2015]

5. Norway pubmed.ncbi.nlm.nih.gov

Maintenance intravenous fluid prescribing practices among paediatric residents. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Administration of 3% Sodium Chloride and Local Infusion Reactions. [2022]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of peripherally administered 3% hypertonic saline. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Analysis of potential risks associated with 7.5% sodium chloride resuscitation of traumatic shock. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Improving intravenous fluid therapy in children with gastroenteritis. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. [2015]