NCT04781361

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

Comparison of the Effects of Isotonic and Hypotonic Intravenous Maintenance Fluids on Term Neonatal Babies Undergoing Intravenous Fluid Therapy: Multicenter Observational Neofluid Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 420 (actual)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: —

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.

Conditions

• Newborn Complication
• Hyponatremia of Newborn
• Hypernatremia of Newborn
• Fluid Therapy
• Sodium Chloride
• Isotonic Dehydration

Interventions

Type	Name	Description
DRUG	Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose	Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
DRUG	Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L	Hypotonic group will be given fluids containing lower than 130 mmol/L : Dextrose 5% in 0.2% Sodium Chloride, or Dextrose 5% in 0.33 % Sodium Chloride,or Dextrose 5% in %0.45 Sodium Chloride, or Intravenous fluid containing Sodium Chloride \< 130 mmol/L

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2021-03-04
• Last updated: 2023-07-27

Locations

1 site across 1 country: Turkey (Türkiye)