An observational study in Newborn Complication, Hyponatremia of Newborn and Hypernatremia of Newborn, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Dokuz Eylul University · Observational
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.
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's enrollment of 420 is above the median of 105 across 46 observational studies indexed under Dehydration.
Browse Dehydration studies →Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalized term newborns (>37 weeks) , requiring iv fluid treatment after 24 hour postnatal age
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Newborns with diagnoses that required specific fluid tonicity and volumes such as:
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
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
Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
Also known as: B05BB02, 0.9% NaCl/Dextrose 5%
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
Also known as: B05BB02, 0.45% NaCl/5% dextrose, B05BB02, 0.33 % NaCl/5% dextrose, B05BB02, 0.20 % NaCl/5% dextrose
Change in mean plasma Na
Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour)
Time frame: 24 hours after the intervention
Rate of development of hyponatremia
Plasma sodium (pNa) level \<135 mmol/L
Time frame: during the intervention
Rate of development of hypernatremia
Plasma sodium (pNa) level \>145 mmol/L
Time frame: during the intervention
Weight in kilograms
weight gain
Time frame: during the intervention
length of stay
hospitalisation day
Time frame: during the intervention
mortality
mortality due to complications of administered fluid
Time frame: during the intervention
Plan to share: No
Ran from Dec 2020 to primary completion in Dec 2022, 24 months.
Of 19 observational studies under Dehydration, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's 24 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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