Clinical trial NCT04781361: Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study
Official title: Comparison of the Effects of Isotonic and Hypotonic Intravenous Maintenance Fluids on Term Neonatal Babies Undergoing Intravenous Fluid Therapy: Multicenter Observational Neofluid Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn Complication
Hyponatremia of Newborn
Hypernatremia of Newborn
Fluid Therapy
Sodium Chloride
Isotonic Dehydration
Keywords: Newborn, fluid therapy, isotonic, hypotonic,NaCl
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
name: Dr. Behcet Uz Children's Hospital
name: Eskisehir Osmangazi University
name: Necmettin Erbakan University
name: NCR International Hospital
name: Uşak University
name: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Aydin Adnan Menderes University
name: Inonu University
name: Baskent University
name: Kecioren Education and Training Hospital
name: Istanbul University
name: Istanbul Medeniyet University
name: Dr. Lutfi Kirdar Kartal Training and Research Hospital
name: Kanuni Sultan Suleyman Training and Research Hospital
name: Medipol University
name: Cukurova University
name: Mersin Training and Research Hospital
name: Cigli Regional Training Hospital
name: Gulhane School of Medicine
name: Ministry of Health University, Bursa Yüksek İhtisas Training and Research Hospital
name: Yuksek Ihtisas University
name: Ministry of Health University, Kayseri Regional Hospital
name: Suleyman Demirel University
name: Konya Private Medova Hospital
name: Ankara Yildirim Beyazıt University
name: Cumhuriyet University
name: Aydın Maternity and Children Hospital
name: Umraniye Education and Research Hospital
name: Selcuk University
name: Mersin University
name: Istanbul University - Cerrahpasa
First posted: 2021-03-04
Enrollment: 420
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized term newborns (\>37 weeks) , requiring iv fluid treatment after 24 hour postnatal age

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean plasma Na
timeFrame: 24 hours after the intervention
measure: Rate of development of hyponatremia
timeFrame: during the intervention
measure: Rate of development of hypernatremia
timeFrame: during the intervention
Secondary outcomes:
measure: Weight in kilograms
timeFrame: during the intervention
measure: length of stay
timeFrame: during the intervention
measure: mortality
timeFrame: during the intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylül University- Faculty of Medicine
name: Hasan Ozkan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Clinical Guideline Centre. IV Fluids in Children: Intravenous Fluid Therapy in Children and Young People in Hospital. London: National Institute for Health and Care Excellence (UK); 2015 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK338141/
citation: Balasubramanian K, Kumar P, Saini SS, Attri SV, Dutta S. Isotonic versus hypotonic fluid supplementation in term neonates with severe hyperbilirubinemia - a double-blind, randomized, controlled trial. Acta Paediatr. 2012 Mar;101(3):236-41. doi: 10.1111/j.1651-2227.2011.02508.x. Epub 2011 Nov 19.
citation: McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A, Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. Cochrane Database Syst Rev. 2014 Dec 18;2014(12):CD009457. doi: 10.1002/14651858.CD009457.pub2.
citation: Tuzun F, Akcura Y, Duman N, Ozkan H. Comparison of isotonic and hypotonic intravenous fluids in term newborns: is it time to quit hypotonic fluids. J Matern Fetal Neonatal Med. 2022 Jan;35(2):356-361. doi: 10.1080/14767058.2020.1718094. Epub 2020 Mar 29.