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

CompletedOBSERVATIONAL
Enrollment

420

Participants

Timeline

Start Date

December 30, 2020

Primary Completion Date

December 31, 2022

Study Completion Date

June 30, 2023

Conditions
Newborn ComplicationHyponatremia of NewbornHypernatremia of NewbornFluid TherapySodium ChlorideIsotonic 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"

Trial Locations (1)

35340

Dokuz Eylul University, Izmir

Sponsors
All Listed Sponsors
collaborator

Izmir Katip Celebi University

OTHER

collaborator

Dr. Behcet Uz Children's Hospital

OTHER

collaborator

Eskisehir Osmangazi University

OTHER

collaborator

Necmettin Erbakan University

OTHER

collaborator

NCR International Hospital

UNKNOWN

collaborator

Uşak University

OTHER

collaborator

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

collaborator

Aydin Adnan Menderes University

OTHER

collaborator

Inonu University

OTHER

collaborator

Baskent University

OTHER

collaborator

Kecioren Education and Training Hospital

OTHER

collaborator

Istanbul University

OTHER

collaborator

Istanbul Medeniyet University

OTHER

collaborator

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

collaborator

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

collaborator

Medipol University

OTHER

collaborator

Cukurova University

OTHER

collaborator

Mersin Training and Research Hospital

OTHER_GOV

collaborator

Cigli Regional Training Hospital

OTHER

collaborator

Gulhane School of Medicine

OTHER

collaborator

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

UNKNOWN

collaborator

Yuksek Ihtisas University

OTHER

collaborator

Ministry of Health University, Kayseri Regional Hospital

UNKNOWN

collaborator

Suleyman Demirel University

OTHER

collaborator

Konya Private Medova Hospital

UNKNOWN

collaborator

Ankara Yildirim Beyazıt University

OTHER

collaborator

Cumhuriyet University

OTHER

collaborator

Aydın Maternity and Children Hospital

UNKNOWN

collaborator

Umraniye Education and Research Hospital

OTHER_GOV

collaborator

Selcuk University

OTHER

collaborator

Mersin University

OTHER

collaborator

Istanbul University - Cerrahpasa

OTHER

lead

Dokuz Eylul University

OTHER