| CTRI Number |
CTRI/2025/12/098833 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to identify Which intravenous fluid is better among the commonly used two types of fluid called dextrose normal saline and half dextrose normal saline respectively in terms of maintaining salt and sugar level maintenance in a child age group between 28 days to 12 months. |
|
Scientific Title of Study
|
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 Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrinmoy Roy |
| Designation |
Senior resident, department Of pediatric Medicine |
| Affiliation |
IPGMER and SSKM hospital |
| Address |
Alex-1 ward, pediatrics medicine department, IPGMER and SSKM hospital 244,A.J.C. Bose road, kolkata- 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9474494762 |
| Fax |
|
| Email |
roymrinmoy7890@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyabrata Roy Chowdhoury |
| Designation |
Assistant professor, department Of pediatric Medicine |
| Affiliation |
IPGMER and SSKM hospital |
| Address |
Alex-1 ward, pediatrics medicine department, IPGMER and SSKM hospital 244,A.J.C. Bose road, kolkata- 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433765529 |
| Fax |
|
| Email |
satamck@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyabrata Roy Chowdhoury |
| Designation |
Assistant professor, department Of pediatric Medicine |
| Affiliation |
IPGMER and SSKM hospital |
| Address |
Alex-1 ward, pediatrics medicine department, IPGMER and SSKM hospital 244,A.J.C. Bose road, kolkata- 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433765529 |
| Fax |
|
| Email |
satamck@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MRINMOY ROY |
| Address |
IPGMER and SSKM,244,A.J.C bose road, kolkata-700020 |
| Type of Sponsor |
Other [Self] |
|
|
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 SATYABRATA ROY CHOWDHURY |
IPGMER and SSKM hospital |
Alex-1 ward, pediatrics medicine department, IPGMER and SSKM hospital 244,A.J.C. Bose road, kolkata- 700020
Kolkata
WEST BENGAL |
9433765529
satamck@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DNS fluid to those sick children who will be requiring more than 50 percentage of total fluid requirement via intravenous route for more than 24 hours |
In stage 1, all the eligible children (age group 28 days to 1 year) fulfilling the inclusion and exclusion criteria will be stabilized and started on maintenance intravenous fluids as per standard protocols.
In Stage 2, participants will be randomized using computer-generated random numbers into two groups.
Group A Will receive prepacked DNS at maintenance rate, calculated according to the Holliday-Segar method.
Group B Will receive prepacked half DNS at maintenance rate, calculated using the same method.
Monitoring will be based on Serum sodium, potassium, chloride, blood urea nitrogen (BUN), and creatinine.
Clinical parameters are urine output and overall fluid balance.
Monitoring windows will be Baseline (0–2 hours), 12 hours,24 hours and 72 hours after initiation of therapy.
Dysnatremia is defined as Hyponatremia where serum sodium level less than 135 milliequivalent per liter and hypernatremia as serum sodium more than 145 milliequivalent per liter. At any point of dysnatremia the intervention will be stopped, participants will be withdrawn from the study, and the they will be treated as per clinician decision.
Dysglycemia is defined as hypoglycemia less than 54 milligram per deciliter, hyperglycemia is defined more than 180 milligram per deciliter. At any point of dysglycemia, the intervention will be stopped and the patient will be treated as per clinician decision.
If weight gain or loss more than 10 percentage or any neurological and gastrointestinal side effects noted, the intervention will be stopped and the patient will be treated as per clinician decision.
Any derangements will be documented and corrected as per institutional protocol.
|
| Comparator Agent |
Half DNS fluid to those sick children who will be requiring more than 50 percentage of total fluid requirement via intravenous route for more than 24 hours |
In stage 1, all the eligible children (age group 28 days to 1 year) fulfilling the inclusion and exclusion criteria will be stabilized and started on maintenance intravenous fluids as per standard protocols. In Stage 2, participants will be randomized using computer-generated random numbers into two groups. Group A Will receive prepacked DNS at maintenance rate, calculated according to the Holliday-Segar method. Group B Will receive prepacked half DNS at maintenance rate, calculated using the same method. Monitoring will be based on Serum sodium, potassium, chloride, blood urea nitrogen (BUN), and creatinine. Clinical parameters are urine output and overall fluid balance. Monitoring windows will be Baseline (0–2 hours), 12 hours,24 hours and 72 hours after initiation of therapy. Dysnatremia is defined as Hyponatremia where serum sodium level less than 135 milliequivalent per liter and hypernatremia as serum sodium more than 145 milliequivalent per liter. At any point of dysnatremia the intervention will be stopped, participants will be withdrawn from the study, and the they will be treated as per clinician decision. Dysglycemia is defined as hypoglycemia less than 54 milligram per deciliter, hyperglycemia is defined more than 180 milligram per deciliter. At any point of dysglycemia, the intervention will be stopped and the patient will be treated as per clinician decision. If weight gain or loss more than 10 percentage or any neurological and gastrointestinal side effects noted, the intervention will be stopped and the patient will be treated as per clinician decision. Any derangements will be documented and corrected as per institutional protocol. |
|
|
Inclusion Criteria
|
| Age From |
28.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in serum sodium level is the primary outcome.
Dysnatremia is defined as hyponatremia where serum sodium level less than 135 milliequivalent per liter and hypernatremia as serum sodium more than 145 milliequivalent per liter. At any point of dysnatremia the intervention will be stopped, participants will be withdrawn from the study, and the they will be treated as per clinician decision. |
Monitoring windows will be baseline (0–2 hours), 12 hours,24 hours and 72 hours after initiation of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum glucose is the secondary outcome.Dysglycemia is defined as hypoglycemia less than 54 milligram per deciliter, hyperglycemia is defined more than 180 milligram per deciliter. At any point of dysglycemia, the intervention will be stopped and the patient will be treated as per clinician decision |
Monitoring windows will be baseline (0–2 hours), 12 hours,24 hours and 72 hours after initiation of therapy. |
Weight gain or loss more than 10 percentage or any neurological and gastrointestinal side effects are secondary outcome. If noted, the intervention will be stopped and the patient will be treated as per clinician decision.
Any derangements will be documented and corrected as per institutional protocol. |
Monitoring windows will be baseline (0–2 hours), 12 hours,24 hours and 72 hours after initiation of therapy. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |