| CTRI Number |
CTRI/2017/05/008585 [Registered on: 17/05/2017] Trial Registered Prospectively |
| Last Modified On: |
07/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Maintenance Fluids In Newborns |
|
Scientific Title of Study
|
Comparison of isotonic versus hypotonic intravenous fluid for maintenance fluid therapy in neonates more than or equal to 34 weeks of gestational age – A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Dathan |
| Designation |
RESIDENT NEONATOLOGY |
| Affiliation |
DR MEHTA HOSPITAL |
| Address |
Department of Neonatology ,Dr Mehta Childrens Hospital,No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
|
| Fax |
|
| Email |
krishnadathan85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S MANGALABHARATHI |
| Designation |
CONSULTANT |
| Affiliation |
DR MEHTA HOSPITAL |
| Address |
Department of Neonatology ,Dr Mehta Childrens Hospital,No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
|
| Fax |
|
| Email |
drmangalabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Dathan |
| Designation |
RESIDENT NEONATOLOGY |
| Affiliation |
DR MEHTA HOSPITAL |
| Address |
Department of Neonatology ,Dr Mehta Childrens Hospital,No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
|
| Fax |
|
| Email |
krishnadathan85@gmail.com |
|
|
Source of Monetary or Material Support
|
| ,Dr Mehta Childrens Hospital,No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031 |
|
|
Primary Sponsor
|
| Name |
Dr Mehta Childrens Hospital |
| Address |
No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Dathan |
Department of Neonatology ,Dr Mehta Childrens Hospital |
No 2 McNichols Road,3rd Lane ,Chetpet , Chennai,Tamil Nadu ,India 600031
Chennai
TAMIL NADU |
9599553720
krishnadathan85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEHTA CHILDRENS HOSPITAL PRIVATE LIMITED ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonates requiring maintenance intravenous fluid therapy , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
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 |
| Intervention |
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 |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hyponatremia (defined as serum sodium 135mEq/L) in both the groups. |
AT 24 HOURS AFTER STARTING MAINTENANCE FLUID |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. 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
|
. 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
|
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a double blinded randomized controlled trial comparing the safety and efficacy of isotonic versus standard hypotonic maintenance fluid in neonates more than or equal to 34 weeks of gestation at birth who are more than 48 hours of life to observe the incidence of hyponatremia and/ or hypernatremia and variations in serum sodium ,serum osmolality , weight , urine output , final clinical outcome with the use of two types of maintenance fluids.
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