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CTRI Number  CTRI/2025/08/093338 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   Low blood sodium levels among children(1 month-12 years) at admission in pediatric emergency  
Scientific Title of Study   Hyponatremia among children(1 month -12 years) at admission in pediatric emergency 
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 Sagar Joshi 
Designation  post graduate resident 
Affiliation  Lok Nayak Hospital New Delhi 
Address  Dept of pediatrics Maulana Azad Medical College Lok Nayak Hospital New Delhi

Central
DELHI
110002
India 
Phone  7252965585  
Fax    
Email  sagar.joshij99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pallavi 
Designation  Associate professor 
Affiliation  Lok Nayak Hospital New Delhi 
Address  Dept of pediatrics Maulana Azad Medical College Lok Nayak Hospital New Delhi

Central
DELHI
110002
India 
Phone  9871164305  
Fax    
Email  pallavi86.delhi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pallavi 
Designation  Associate professor 
Affiliation  Lok Nayak Hospital New Delhi 
Address  Dept of pediatrics Maulana Azad Medical College Lok Nayak Hospital New Delhi

Central
DELHI
110002
India 
Phone  9871164305  
Fax    
Email  pallavi86.delhi@gmail.com  
 
Source of Monetary or Material Support  
dept of pediatrics Maulana Azad Medical College  
 
Primary Sponsor  
Name  Dr Sagar Joshi 
Address  dept of pediatrics Maulana Azad Medical College Lok Nayak Hospital New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
sagar  lok nayak hospital  Department of pediatrics
Central
DELHI 		 7252965585

sagar.joshij99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee maulana azad medical college new delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between 1 month to 12 years of age admitted to the pediatric emergency.  
 
ExclusionCriteria 
Details  1. Patients who have received sodium containing fluid from outside.
2. Patients with chronic kidney disease, nephrotic syndrome, Addison’s disease
3. Patients coming for day care services to emergency or admitted for some
investigation/injection or infusion.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of children with hyponatremia (Serum Na less than 135mEq/L)  Proportion of children with hyponatremia (Serum Na less than 135mEq/L) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of in-hospital mortality among children with hyponatremia.
2. Association of hyponatremia with risk factors like age, diagnosis, nutritional status (body mass index or weight for length), pediatrics early warning
score (PEWS).
 		 1week 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   04/09/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included sagar.joshij99@gmail.com).

  6. For how long will this data be available start date provided 23-07-2026 and end date provided 23-07-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Hyponatremia is a frequently encountered electrolyte abnormality among children presenting to emergency with various medical conditions. Several causes of hyponatremia exist and can be classified based on the volume status. Multiple studies in the adults, including thousands of patients with heart, liver, and pulmonary diseases, reveal that hyponatremia is strongly associated with a more severe disease course and higher overall mortality. 

This study is a prospective observational study which  investigates the proportion of hyponatremia in children at the time of admission in pediatric emergency department. Furthermore, study will also compare the outcomes of hyponatremic children in terms of length of hospitalization and mortality with children having normonatremia.

 
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