DNS versus half DNS as a choice of maintenance fluid in treatment of sick children age group 28 days to 1 year in Pediatrics, a randomized Controlled Trial in a tertiary care center of eastern india
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
Study Overview
Brief Summary
Intravenous fluid therapy is an essential component in the management of sick children, yet inappropriate composition of maintenance fluids may lead to serious electrolyte disturbances, particularly hyponatremia. Infants between 28 days and 12 months of age are especially vulnerable because of their immature renal physiology and increased antidiuretic hormone secretion during illness. Although hypotonic fluids such as half DNS are widely used in pediatric practice, recent evidence indicates that isotonic fluids may be safer for preventing hospital-acquired hyponatremia; on the other hand, there is an issue of hypernatremia with isotonic fluids as maintenance. The present study proposes to evaluate and compare the safety of DNS and half DNS as maintenance fluids in this age group, with particular focus on electrolyte balance and related complications. This will be conducted as a randomized controlled trial in a tertiary care centre, with close monitoring of serum electrolytes and clinical outcomes. The results are expected to generate locally relevant evidence to inform safer fluid prescribing practices in infants and contribute to improved quality of care in hospitalized children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 28.00 Day(s) to 12.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •Those sick children of the age group 28 days to 12 months who will be admitted for acute illness will require more than 50 percent of their total fluid requirement via the intravenous route for more than 24 hours.
Exclusion Criteria
- •Parents or patients not giving consent or assent, respectively Hemodynamic shock needing boluses or inotropes.
- •Baseline sodium less than 135 mmol per litre or more than 145 mmol per litre, or glucose less than 54 mg per deciliter at presentation.
- •patient receiving sodium therapy for any reason.
Investigators
Dr Mrinmoy Roy
IPGMER and SSKM hospital