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

Study Overview
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Brief Summary
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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.

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

Conditions
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Newborn Complication, Hyponatremia of Newborn, Hypernatremia of Newborn, Fluid Therapy, Sodium Chloride, Isotonic Dehydration

Intervention / Treatment
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* Drug: Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose
* Drug: Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria are: Term newborns (>37 + 0/7 weeks) aged 24 hours to 30 days with a normal baseline serum sodium level between 135-145 mmol/L,with a treatment plan to include IV fluids at > 50% of maintenance Infants not received parenteral fluids in the last 24 hours before participation Infants receiving IV fluid administration at 50% to 100% of maintenance 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Isotonic fluid<br>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 | Drug: Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose<br>* Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride<br>* Other names: B05BB02, 0.9% NaCl/Dextrose 5%;|
| Hypotonic fluid<br>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 | Drug: Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L<br>* 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<br>* Other names: B05BB02, 0.20 % NaCl/5% dextrose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean plasma Na | Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour) | 24 hours after the intervention | 
| Rate of development of hyponatremia | Plasma sodium (pNa) level <135 mmol/L | during the intervention | 
| Rate of development of hypernatremia | Plasma sodium (pNa) level >145 mmol/L | during the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight in kilograms | weight gain | during the intervention | 
| length of stay | hospitalisation day | during the intervention | 
| mortality | mortality due to complications of administered fluid | during the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, fluid therapy, isotonic, hypotonic,NaCl