Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study

Completed

• Conditions: Newborn Complication; Sodium Chloride; Hyponatremia of Newborn; Isotonic Dehydration; Hypernatremia of Newborn; Fluid Therapy
• Interventions: Drug: Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose; Drug: Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L

• Registration Number: NCT04781361
• Lead Sponsor: Dokuz Eylul University

Brief Summary

Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia.

Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation.

The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic.

In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) \< 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-30
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Not provided

Exclusion Criteria

• Newborns with diagnoses that required specific fluid tonicity and volumes such as:

  • Severe dehydration presenting with shock
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
  • Renal insufficiency
  • Adrenal insufficiency
  • Diabetes mellitus and diabetes insipidus
  • Hypoxic ischemic encephalopathy
  • Major congenital anomaly
  • Patients receiving diuretic therapy
  • Patients with obvious edema
  • Heart or liver failure, portal hypertension with acid
  • Pre-post operative patients
  • Infants receiving total parenteral nutritional therapy
  • Other: all conditions that require non-standard liquid content and quantities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Isotonic fluid	Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose	Group, received isotonic maintenance fluid containing NaCl between 131 to 154 mmol/L such as: * Dextrose 5% in 0.9% NaCl, * Intravenous fluid containing NaCl between 131 to 154 mmol/L
Hypotonic fluid	Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L	Group, received hypotonic maintenance fluid containing NaCl \< 130 mmol/L such as: * Dextrose 5 % in 0.02 % NaCl, * Dextrose 5% in 0.033 % NaCl * Dextrose 5% in 0.045 % NaCl * Intravenous fluid containing NaCl \< 130 mmol/L

Primary Outcome Measures

Name	Time	Method
Rate of development of hypernatremia	during the intervention	Plasma sodium (pNa) level \>145 mmol/L
Change in mean plasma Na	24 hours after the intervention	Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour)
Rate of development of hyponatremia	during the intervention	Plasma sodium (pNa) level \<135 mmol/L

Secondary Outcome Measures

Name	Time	Method
Weight in kilograms	during the intervention	weight gain
length of stay	during the intervention	hospitalisation day
mortality	during the intervention	mortality due to complications of administered fluid

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 İzmir, Turkey