Status:
COMPLETED
Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study
Lead Sponsor:
Dokuz Eylul University
Collaborating Sponsors:
Izmir Katip Celebi University
Dr. Behcet Uz Children's Hospital
Conditions:
Newborn Complication
Hyponatremia of Newborn
Eligibility:
All Genders
1-30 years
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 desi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04781361
Start Date
December 30 2020
End Date
June 30 2023
Last Update
July 27 2023
Active Locations (1)
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1
Dokuz Eylul University
Izmir, Turkey (Türkiye), 35340