Comparing the prevalence of dysnatremia between two methods of intravenous fluid therapy, Half-saline and the conventional 0.2 saline solutions in term neonates

Incidence of dysnatremia during maintenance intravenous fluid therapy in term neonates with sepsis: A prospective randomized study comparing half-saline and standard 0.2 saline solutions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017053034223N1

Enrollment

Registered

2017-10-12

Start date

2017-02-19

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial sepsis of newborn. Bacterial sepsis of newborn

Interventions

Intervention 1: Intervention: Using Half-saline solution (75 mEq/L of sodium) as maintenance IV fluid. Intervention 2: Control: Using conventional 0.2 saline solution ( 30 mEq/L of sodium) as maintena

Treatment - Other

Intervention: Using Half-saline solution (75 mEq/L of sodium) as maintenance IV fluid

Control: Using conventional 0.2 saline solution ( 30 mEq/L of sodium) as maintenance IV fluid

Eligibility

Sex/Gender

All

Age

3 Days to 31 Days

Inclusion criteria

Inclusion criteria: inclusion criteria: Term neonates of 38-42 weeks gestation and more than 3 days old admitted with the diagnosis of neonatal sepsis Exclusion criteria: Congenital heart disease; Renal disease; Severe dehydration; dysnatremia; Hyperbilirubinemia

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum Sodium. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Venous Blood Sample, mEq/L.	—

Secondary

Measure	Time frame
Urine Osmolarity. Timepoint: Before intervention and at hours 12, 24, 48. Method of measurement: mOsmol/L.;Serum Potassium. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Blood Sampling, mEq/L.;Serum Creatinine. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Blood Sampling, mg/dL.;BUN. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Blood Sampling, mg/dL.;Urinary output. Timepoint: Before intervention and at hours 24, 48. Method of measurement: ml.	—

Measure

Time frame

Urine Osmolarity. Timepoint: Before intervention and at hours 12, 24, 48. Method of measurement: mOsmol/L.;Serum Potassium. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Blood Sampling, mEq/L.;Serum Creatinine. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Blood Sampling, mg/dL.;BUN. Timepoint: Before intervention and at hours 6, 12, 24, 48. Method of measurement: Blood Sampling, mg/dL.;Urinary output. Timepoint: Before intervention and at hours 24, 48. Method of measurement: ml.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHani Milani

Iran University of Medical Sciences

hanimilani@gmail.com+98 21 2304 6215

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026