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.
Who can participate
Age range
1 Day – 30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared isotonic and hypotonic IV fluids in newborns — if my baby needs IV fluids, which type does our hospital currently use, and has the evidence from studies like this one influenced that practice?
2The trial specifically tracked whether babies developed low or high sodium levels (hyponatremia or hypernatremia) — how will the care team monitor my newborn's sodium if IV fluids are needed, and how quickly would they act if levels shifted?
3Since this trial is completed but I don't have the results in front of me, can you share what the findings showed about which fluid type was safer for sodium balance in term newborns?
4My baby is a term newborn — does that match the population studied here, and does that make the results more or less relevant to our specific situation?
5Are there standard-of-care guidelines already in place for IV fluid choice in term newborns, and would those be a better-established path compared to any newer protocols that might still be under review?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.