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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04781361
Other study ID # 363-SBKAEK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 30, 2020
Est. completion date June 30, 2023

Study information

Verified date July 2023
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 1 Day to 30 Days
Eligibility 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

Study Design


Intervention

Drug:
Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose
Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
Intravenous 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

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (33)

Lead Sponsor Collaborator
Dokuz Eylul University Ankara Yildirim Beyazit University, Aydin Adnan Menderes University, Aydin Maternity and Children Hospital, Baskent University, Cigli Regional Training Hospital, Cukurova University, Cumhuriyet University, Dr. Behcet Uz Children's Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Eskisehir Osmangazi University, Gulhane School of Medicine, Inonu University, Istanbul Medeniyet University, Istanbul University, Istanbul University - Cerrahpasa (IUC), Izmir Katip Celebi University, Kanuni Sultan Suleyman Training and Research Hospital, Kecioren Education and Training Hospital, Konya Private Medova Hospital, Medipol University, Mersin Training and Research Hospital, Mersin University, Ministry of Health University, Bursa Yu¨ksek I?htisas Training and Research Hospital, Ministry of Health University, Kayseri Regional Hospital, NCR International Hospital, Necmettin Erbakan University, Selcuk University, Suleyman Demirel University, Umraniye Education and Research Hospital, Usak University, Yuksek Ihtisas University, Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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;(12):CD009457. doi: 10.1002/14651858.CD009457.pub2. — View 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/ — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean plasma Na Change in mean plasma sodium levels per hour (?pNa mmol/L/hour) 24 hours after the intervention
Primary Rate of development of hyponatremia Plasma sodium (pNa) level <135 mmol/L during the intervention
Primary Rate of development of hypernatremia Plasma sodium (pNa) level >145 mmol/L during the intervention
Secondary Weight in kilograms weight gain during the intervention
Secondary length of stay hospitalisation day during the intervention
Secondary mortality mortality due to complications of administered fluid during the intervention
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