NCT04781361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

February 4, 2021

Last Update Submit

July 25, 2023

Conditions

Newborn ComplicationHyponatremia of NewbornHypernatremia of NewbornFluid TherapySodium ChlorideIsotonic Dehydration

Keywords

Newborn, fluid therapy, isotonic, hypotonic,NaCl

Outcome Measures

Primary Outcomes (3)

  • Change in mean plasma Na

    Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour)

    24 hours after the intervention

  • Rate of development of hyponatremia

    Plasma sodium (pNa) level \<135 mmol/L

    during the intervention

  • Rate of development of hypernatremia

    Plasma sodium (pNa) level \>145 mmol/L

    during the intervention

Secondary Outcomes (3)

  • Weight in kilograms

    during the intervention

  • length of stay

    during the intervention

  • mortality

    during the intervention

Study Arms (2)

Isotonic fluid

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

Hypotonic fluid

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

Interventions

Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextroseDRUG

Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride

Also known as: B05BB02, 0.9% NaCl/Dextrose 5%
Isotonic fluid
Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/LDRUG

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
Hypotonic fluid

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Hospitalized term newborns (\>37 weeks) , requiring iv fluid treatment after 24 hour postnatal age

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (4)

  • 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/

    PMID: 26741016BACKGROUND

  • 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.

    PMID: 22040311BACKGROUND

  • 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.

    PMID: 25519949BACKGROUND

  • 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.

    PMID: 32223482BACKGROUND

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Hasan Ozkan, Prof.

    Dokuz Eylül University- Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor of Neonatology

Study Record Dates

First Submitted

February 4, 2021

First Posted

March 4, 2021

Study Start

December 30, 2020

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)