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

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.

Conditions

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

Interventions

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

DRUG

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

Sponsors & Collaborators

• Izmir Katip Celebi University

  collaborator OTHER

• Dr. Behcet Uz Children's Hospital

  collaborator OTHER

• Eskisehir Osmangazi University

  collaborator OTHER

• Necmettin Erbakan University

  collaborator OTHER

• NCR International Hospital

  collaborator UNKNOWN

• Uşak University

  collaborator OTHER

• Zekai Tahir Burak Women's Health Research and Education Hospital

  collaborator OTHER

• Aydin Adnan Menderes University

  collaborator OTHER

• Inonu University

  collaborator OTHER

• Baskent University

  collaborator OTHER

• Kecioren Education and Training Hospital

  collaborator OTHER

• Istanbul University

  collaborator OTHER

• Istanbul Medeniyet University

  collaborator OTHER

• Dr. Lutfi Kirdar Kartal Training and Research Hospital

  collaborator OTHER_GOV

• Kanuni Sultan Suleyman Training and Research Hospital

  collaborator OTHER

• Medipol University

  collaborator OTHER

• Cukurova University

  collaborator OTHER

• Mersin Training and Research Hospital

  collaborator OTHER_GOV

• Cigli Regional Training Hospital

  collaborator OTHER

• Gulhane School of Medicine

  collaborator OTHER

• Ministry of Health University, Bursa Yüksek İhtisas Training and Research Hospital

  collaborator UNKNOWN

• Yuksek Ihtisas University

  collaborator OTHER

• Ministry of Health University, Kayseri Regional Hospital

  collaborator UNKNOWN

• Suleyman Demirel University

  collaborator OTHER

• Konya Private Medova Hospital

  collaborator UNKNOWN

• Ankara Yildirim Beyazıt University

  collaborator OTHER

• Cumhuriyet University

  collaborator OTHER

• Aydın Maternity and Children Hospital

  collaborator UNKNOWN

• Umraniye Education and Research Hospital

  collaborator OTHER_GOV

• Selcuk University

  collaborator OTHER

• Mersin University

  collaborator OTHER

• Istanbul University - Cerrahpasa

  collaborator OTHER

• Dokuz Eylul University

  lead OTHER

Principal Investigators

• Hasan Ozkan, Prof. · Dokuz Eylül University- Faculty of Medicine

Eligibility

Min Age

1 Day

Max Age

30 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-30

Primary Completion

2022-12-31

Completion

2023-06-30

Countries

• Turkey (Türkiye)

Study Locations