Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study

Fluid Therapy Clinical Trial

— NEOFLUID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781361
• Other study ID #: 363-SBKAEK
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Dehydration
• Fluid Therapy
• Hypernatremia
• Hypernatremia of Newborn
• Hyponatremia
• Hyponatremia of Newborn
• Isotonic Dehydration
• Newborn Complication
• Sodium Chloride

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

External Links

•   Turkish Neonatology Society, Diagnosis and Treatment Guidelines, 2015