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NCT Number: NCT04781361

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

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.

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Key information

Conditions

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

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: B05BB02, 0.9% NaCl/Dextrose 5%

Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L

Drug

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 names: B05BB02, 0.45% NaCl/5% dextrose, B05BB02, 0.33 % NaCl/5% dextrose, B05BB02, 0.20 % NaCl/5% dextrose

Primary outcomes

  1. Change in mean plasma Na

    Time frame: 24 hours after the intervention

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

  2. Rate of development of hyponatremia

    Time frame: during the intervention

    Plasma sodium (pNa) level <135 mmol/L

  3. Rate of development of hypernatremia

    Time frame: during the intervention

    Plasma sodium (pNa) level >145 mmol/L

Secondary outcomes

  1. Weight in kilograms

    Time frame: during the intervention

    weight gain

  2. length of stay

    Time frame: during the intervention

    hospitalisation day

  3. mortality

    Time frame: during the intervention

    mortality due to complications of administered fluid

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Ankara Yildirim Beyazıt University
  • Aydin Adnan Menderes University
  • Aydın 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
  • 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 Yüksek İhtisas 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
  • Uşak University
  • Yuksek Ihtisas University
  • Zekai Tahir Burak Women's Health Research and Education Hospital

Registry information

Official study title

Comparison of the Effects of Isotonic and Hypotonic Intravenous Maintenance Fluids on Term Neonatal Babies Undergoing Intravenous Fluid Therapy: Multicenter Observational Neofluid Study

Acronym: NEOFLUID

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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