Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study
NCT ID: NCT04781361
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
420 participants
OBSERVATIONAL
2020-12-30
2023-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose
Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
30 Days
ALL
No
Sponsors
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Izmir Katip Celebi University
OTHER
Dr. Behcet Uz Children's Hospital
OTHER
Eskisehir Osmangazi University
OTHER
Necmettin Erbakan University
OTHER
NCR International Hospital
UNKNOWN
Uşak University
OTHER
Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Aydin Adnan Menderes University
OTHER
Inonu University
OTHER
Baskent University
OTHER
Kecioren Education and Training Hospital
OTHER
Istanbul University
OTHER
Istanbul Medeniyet University
OTHER
Dr. Lutfi Kirdar Kartal Training and Research Hospital
OTHER_GOV
Kanuni Sultan Suleyman Training and Research Hospital
OTHER
Medipol University
OTHER
Cukurova University
OTHER
Mersin Training and Research Hospital
OTHER_GOV
Cigli Regional Training Hospital
OTHER
Gulhane School of Medicine
OTHER
Ministry of Health University, Bursa Yüksek İhtisas Training and Research Hospital
UNKNOWN
Yuksek Ihtisas University
OTHER
Ministry of Health University, Kayseri Regional Hospital
UNKNOWN
Suleyman Demirel University
OTHER
Konya Private Medova Hospital
UNKNOWN
Ankara Yildirim Beyazıt University
OTHER
Cumhuriyet University
OTHER
Aydın Maternity and Children Hospital
UNKNOWN
Umraniye Education and Research Hospital
OTHER_GOV
Selcuk University
OTHER
Mersin University
OTHER
Istanbul University - Cerrahpasa
OTHER
Dokuz Eylul University
OTHER
Responsible Party
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Funda Tuzun
M.D., Associate Professor of Neonatology
Principal Investigators
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Hasan Ozkan, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylül University- Faculty of Medicine
Locations
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Dokuz Eylul University
Izmir, , Turkey (Türkiye)
Countries
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References
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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/
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.
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.
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.
Other Identifiers
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363-SBKAEK
Identifier Type: -
Identifier Source: org_study_id
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