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CTRI Number  CTRI/2026/01/102239 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Magnesium Sulphate Injection In Acute Severe Bronchiolitis 
Scientific Title of Study   Role Of Magnesium Sulphate Injection In Acute Severe Bronchiolitis a Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MIHIR SARKAR 
Designation  PROFESSOR PEDIATRICS 
Affiliation  Medical College Kolkata  
Address  Department of Pediatrics Medical College Kolkata 88, College Street Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  8961616284  
Fax    
Email  drmihir09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MIHIR SARKAR 
Designation  PROFESSOR PEDIATRICS 
Affiliation  Medical College Kolkata  
Address  Department of Pediatrics Medical College Kolkata 88, College Street Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  8961616284  
Fax    
Email  drmihir09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MIHIR SARKAR 
Designation  PROFESSOR PEDIATRICS 
Affiliation  Medical College Kolkata  
Address  Department of Pediatrics Medical College Kolkata 88, College Street Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  8961616284  
Fax    
Email  drmihir09@gmail.com  
 
Source of Monetary or Material Support  
Medical College and Hospital Kolkata 88 College Street College Square Kolkata 700001 India 
 
Primary Sponsor  
Name  Medical College Kolkata 
Address  88 College Street Kolkata - 700073 
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 
Dr Mihir Sarkar  Medical College Kolkata  88 College Street Kolkata 700073 India Department of Pediatrics Mother and Child Hub
Kolkata
WEST BENGAL 
8961616284

drmihir09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug  Intravenous Magnesium Sulphate at a dose of 50 mg/kg, diluted in normal saline and infused over 30 minutes, administered every 8 hours for 24 hours (total of three doses). 
Comparator Agent  Standard Therapy  Standard recommended Management of Bronchiolitis 
 
Inclusion Criteria  
Age From  28.00 Day(s)
Age To  24.00 Month(s)
Gender  Both 
Details  Children with Acute Severe Bronchiolitis 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the efficacy of intravenous magnesium sulphate in
reducing respiratory distress, as measured by the Respiratory Distress Assessment
Instrument (RDAI), in infants with acute severe bronchiolitis. 
2, 6, 12, 24, 48, 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Escalation of respiratory support (HFNC, CPAP, intubation), duration of PICU stay, serum magnesium levels, & adverse events.  24,48,72 hours 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   12/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
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  

The rationale behind studying the role of magnesium sulfate in acute bronchiolitis lies in its potential to alleviate symptoms and improve outcomes in patients with this condition. Acute bronchiolitis is a common lower respiratory tract infection, especially in infants and young children, often caused by viral infections such as respiratory syncytial virus (RSV).

Acute bronchiolitis is primarily caused by viral infections, with respiratory syncytial virus (RSV) being a common culprit. It leads to inflammation and narrowing of the small airways in the lungs, resulting in symptoms such as wheezing, coughing, and difficulty breathing.

Current treatments for acute bronchiolitis focus on supportive care, such as oxygen therapy, hydration, and sometimes the use of bronchodilators like Salbutamol. However, these treatments may not always provide sufficient relief or improve outcomes significantly, especially in severe cases.

Magnesium sulfate has attracted attention due to its potential bronchodilator and anti-inflammatory properties. It is thought to relax smooth muscles in the airways, reduce bronchoconstriction, and modulate inflammatory responses. These mechanisms suggest that magnesium sulfate could be beneficial in improving respiratory function and reducing the severity of symptoms in patients with acute bronchiolitis.

Overall, the rationale and introduction of such a study aim to highlight the gap in effective treatments for acute bronchiolitis and the potential of magnesium sulfate as a promising therapeutic option that warrants further investigation through rigorous clinical research.

 
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