Comparison Of Maintenance Fluids In Newborns

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008585
• Date of registration: 17-05-2017
• Prospective Registration: Yes
• Primary sponsor: Dr Mehta Childrens Hospital
• Public title: Comparison Of Maintenance Fluids In Newborns
• Scientific title: 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.
• Date of first enrolment: 01-06-2017
• Target sample size: 102
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17984
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Krishna Dathan
• Affiliation: DR MEHTA HOSPITAL

• Name: Dr S MANGALABHARATHI
• Affiliation: DR MEHTA HOSPITAL

Key inclusion & exclusion 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: 1. Neonates >=34 weeks of gestation and more than 48 hours of age without parental consent.

2. Neonates with hyponatremia (serum sodium <135mEq/L) and hypernatremia (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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 : INTRAVENOUS
DURATION : MINIMUM OF 24 TO MAXIMUM OF 72 HOURS
Control Intervention1: Hypotonic Saline Solution (Isolyte P): DOSE : AS PER STANDARD MAINTENANCE FLUID REQUIUREMENT OF NEONATES NASED ON BODY WEIGHT AND DAY OF LIFE
FREQUENCY : AS 24 HOURS INFUSION
ROUTE : INTRAVENOUS
DURATION : MINIMUM OF 24 TO MAXIMUM OF 72 HOURS

Primary Outcome(s)

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

Secondary Outcome(s)

. 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

Secondary ID(s)

NIL

Source(s) of Monetary Support

,Dr Mehta Childrens Hospital,No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031

Ethics review

Status: Approved
Approval date: 08/10/2016
Contact:

MEHTA CHILDRENS HOSPITAL PRIVATE LIMITED ETHICAL COMMITTEE