| 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
|
|
|
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
|
|
|
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 |
|
|
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. |