Fluid Therapy, Hypernatremia of Newborn, Hyponatremia of Newborn, Isotonic Dehydration, Newborn Complication, Sodium Chloride
Conditions
Keywords
Newborn, fluid therapy, isotonic, hypotonic,NaCl
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.
Interventions
DRUGIntravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose
Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
DRUGIntravenous 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
Sponsors
Izmir Katip Celebi University
Dr. Behcet Uz Children's Hospital
Eskisehir Osmangazi University
Necmettin Erbakan University
NCR International Hospital
Uşak University
Zekai Tahir Burak Women's Health Research and Education Hospital
Aydin Adnan Menderes University
Inonu University
Baskent University
Kecioren Education and Training Hospital
Istanbul University
Istanbul Medeniyet University
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Kanuni Sultan Suleyman Training and Research Hospital
Medipol University
Cukurova University
Mersin Training and Research Hospital
Cigli Regional Training Hospital
Gulhane School of Medicine
Ministry of Health University, Bursa Yüksek İhtisas Training and Research Hospital
Yuksek Ihtisas University
Ministry of Health University, Kayseri Regional Hospital
Suleyman Demirel University
Konya Private Medova Hospital
Ankara Yildirim Beyazıt University
Cumhuriyet University
Aydın Maternity and Children Hospital
Umraniye Education and Research Hospital
Selcuk University
Mersin University
Istanbul University - Cerrahpasa
Dokuz Eylul University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of development of hypernatremia | during the intervention | Plasma sodium (pNa) level \>145 mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | during the intervention | mortality due to complications of administered fluid |
| Weight in kilograms | during the intervention | weight gain |
| length of stay | during the intervention | hospitalisation day |
Countries
Turkey (Türkiye)
Outcome results
None listed