Comparison Of Maintenance Fluids In Newborns

Comparison of isotonic versus hypotonic intravenous fluid for maintenance fluid therapy in neonates more than or equal to 34 weeks of gestational age â?? A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/05/008585

Enrollment

102

Registered

2017-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Neonates requiring maintenance intravenous fluid therapy

Interventions

Intervention1: Isotonic Saline Solution (0.9% DNS): DOSE : AS PER STANDARD MAINTENANCE FLUID REQUIUREMENT OF NEONATES NASED ON BODY WEIGHT AND DAY OF LIFE FREQUENCY : AS 24 HOURS INFUSION ROUTE : INTR

Eligibility

Inclusion criteria

Inclusion criteria: 1) Neonates >=34 weeks of gestation and more than 48 hours of age, who are admitted and anticipated to receive intravenous fluid for the next 24 to 72 hours, are considered for recruitment into the study. 2) Neonates remained eligible if they received an IV bolus of an isotonic fluid before enrolment as long as they are considered euvolemic and only required IV maintenance fluids with no additional rehydration after enrolment.

Exclusion criteria

Exclusion criteria: 1. Neonates >=34 weeks of gestation and more than 48 hours of age without parental consent. 2. Neonates with hyponatremia (serum sodium 145 mEq/L) at the start of study. 3. Neonates who are on medications that affect the sodium homeostasis. 4. Neonates with acute kidney injury at the start of the study. 5. The patients of those neonatologists who are not consenting to be included in the study will be excluded.

Design outcomes

Primary

Measure	Time frame
Incidence of hyponatremia (defined as serum sodium 135mEq/L) in both the groups.Timepoint: AT 24 HOURS AFTER STARTING MAINTENANCE FLUID	—

Secondary

Measure	Time frame
. Secondary outcomes 1. Incidence of hypernatremia (defined as serum sodium 145 mEq/L) during study observation period 2. Incidence of hyponatremia at 48 and 72 hours. 3. Mean serum sodium at 24, 48 and 72 hours. 4. Mean serum osmolality at 24 and 72 hours. 5. Weight gain during study period 6. Edema during study period Timepoint: . Secondary outcomes 1. Incidence of hypernatremia (defined as serum sodium 145 mEq/L) at 24 , 48 , or 72 hours after starting maintenance fluid 2. Incidence of hyponatremia at 48 and 72 hours after starting maintenance fluid 3. Mean serum sodium at 24, 48 and 72 hours after starting maintenance fluid 4. Mean serum osmolality at 24 and 72 hours after starting maintenance fluid 5. Weight gain during study period 6. Edema at 24,48 and 72 hours	—

Measure

Time frame

. Secondary outcomes 1. Incidence of hypernatremia (defined as serum sodium 145 mEq/L) during study observation period 2. Incidence of hyponatremia at 48 and 72 hours. 3. Mean serum sodium at 24, 48 and 72 hours. 4. Mean serum osmolality at 24 and 72 hours. 5. Weight gain during study period 6. Edema during study period Timepoint: . Secondary outcomes 1. Incidence of hypernatremia (defined as serum sodium 145 mEq/L) at 24 , 48 , or 72 hours after starting maintenance fluid 2. Incidence of hyponatremia at 48 and 72 hours after starting maintenance fluid 3. Mean serum sodium at 24, 48 and 72 hours after starting maintenance fluid 4. Mean serum osmolality at 24 and 72 hours after starting maintenance fluid 5. Weight gain during study period 6. Edema at 24,48 and 72 hours

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Countries

India

Contacts

Public ContactDr Krishna Dathan

DR MEHTA HOSPITAL

drmangalabharathi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026