CTRI

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CTRI Number

CTRI/2025/10/095919 [Registered on: 13/10/2025] Trial Registered Prospectively

Last Modified On:

29/08/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Role of intravenous Magnesium Sulphate in moderate to severe Bronchiolitis

Scientific Title of Study

Intravenous Magnesium Sulphate Versus Placebo in clinical recovery time in moderate to severe Bronchiolitis :A Double Blind Randomized Controlled 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	Dr Prachi Parmanand Nikose
Designation	Junior resident
Affiliation	All India Institute of Medical Science , Raipur
Address	All India Institute of Medical science , Raipur , Tatibandh , Chhattisgarh , Plot no 347 , near VMV collage , behind Pritam bhavan , Wardhman nagar , Nagpur 440008 Raipur CHHATTISGARH 492010 India
Phone	9096593982
Fax
Email	prachinikose1@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Tushar Jagzape
Designation	Professor department of Pediatrics
Affiliation	All India Institute of Medical Science , Raipur
Address	All India Institute of Medical science , Raipur , Tatibandh , Chhattisgarh Raipur CHHATTISGARH 492010 India
Phone	9421783796
Fax
Email	tusharjagzape@aiimsraipur.edu.in

Details of Contact Person
Public Query

Name	Dr Tushar Jagzape
Designation	Professor department of Pediatrics
Affiliation	All India Institute of Medical Science , Raipur
Address	All India Institute of Medical science , Raipur , Tatibandh , Chhattisgarh Raipur CHHATTISGARH 492010 India
Phone	9421783796
Fax
Email	tusharjagzape@aiimsraipur.edu.in

Source of Monetary or Material Support

Department of Pediatrics , All India Institute of Medical Sciences (AIIMS) Raipur , Tatibandh ,GE road ,Raipur Chhattisgarh - 492099

Primary Sponsor

Name	Self fundedAll India Institute Of Medical Sciences Raipur
Address	All India Institute Of Medical Sciences, Raipur Tatibandh, G E Road, Raipur Chhattisgarh - Pin No: 492 099 ·
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 Prachi nikose	All India Institute of Medical Sciences AIIMS	First floor C block 1C1and 1C2 ward with ground floor A block PEM ,Department of Pediatrics All India Institute of Medical Sciences Tatibandh Raipur CHHATTISGARH	9096593982 prachinikose1@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institue Ethics Committe All India Institue of Medical science , Raipur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J20-J22\|\|Other acute lower respiratory infections,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Intervention	Intravenous Magnesium sulphate (50%w/v) at 40mg/kg/day diluted in 5 ml NS 1 stat IV dose	Bronchiolitis is disorder of lower respiratory tract which leads lower respiratory airway constriction and inflammation , magnesium sulphate have bronchodilator and anti-inflammatory properties , hence we are trying 40mg/kg stat dose of intravenous magnesium sulphate.
Comparator Agent	Normal saline is used as a placebo will be freshly prepared in a total dilution of 5 ml each and will be administered as 1 single dose intravenously. Standard care is still given to all participants.	Normal saline is used as a placebo in this trials because it is safe, has no therapeutic effect.

Inclusion Criteria

Age From	2.00 Month(s)
Age To	2.00 Year(s)
Gender	Both
Details	All previously healthy children belonging to age group of 2 months to 2 years diagnosed as moderate to severe bronchiolitis according to modified wangs severity scoring system , presenting to AIIMS Raipur

ExclusionCriteria

Details

1, All children requiring mechanical ventilation at presentation or having hemodynamic instability , requiring vasoactive support.
2 History of bronchodilator, corticosteroids use in same episode, those with previous history of wheezing , hemodynamically significant heart disease , immunodeficiency , cystic fibrosis , bronchopulmonary dysplasia .
3Faily history of cardiovascular disorder (arrythmias), neuromuscular weakness , renal pathology will be excluded from the study
4 During hospital stay if child was diagnosed with pneumonia (viral/bacterial) would be eliminated from thesis

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome

TimePoints

The primary outcome of this study is to assess clinical recovery in children aged 2 months to 2 years diagnosed with moderate to severe bronchiolitis. Clinical recovery is defined as achieving a Bronchiolitis Severity Score (BSS) of less than 3. The observations will be conducted for a period of up to 7 days from the time of enrollment or until clinical recovery is achieved, whichever occurs earlier. The primary measure will be the time (in days) taken to reach clinical recovery.

The primary outcome of this study is to assess clinical recovery in children aged 2 months to 2 years diagnosed with moderate to severe bronchiolitis. Clinical recovery is defined as achieving a Bronchiolitis Severity Score (BSS) of less than 3. The BSS will be recorded at 0hrs,2hrs,4hrs,6hrs,9hrs,12hrs,18hrs,24hrs ,thrice daily till clinical recovery acheived in both the magnesium sulphate group and the standard of care group.

Secondary Outcome

Outcome

TimePoints

The secondary outcomes of this study include the proportion (in percentage) of children requiring oxygen support during hospitalization, and the rate of mechanical ventilation among the study participants. The median duration (in days) of hospital stay will be recorded to assess the impact of the intervention on length of hospitalization. The study will also monitor for adverse effects of magnesium sulphate, including decreased urine output and hypotension, throughout the treatment period.

1- 14 days

Target Sample Size

Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3

Date of First Enrollment (India)

20/10/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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
Modification(s)

This double-blind randomized controlled trial investigated the efficacy of intravenous magnesium sulphate compared to placebo in reducing clinical recovery time in children diagnosed with moderate to severe bronchiolitis. The study aimed to evaluate whether magnesium sulphate, known for its potential bronchodilatory and anti-inflammatory effects, could lead to faster recovery in affected pediatric patients. Participants were randomly assigned to receive either magnesium 40mg/kg iv stat dose or a placebo, and their clinical outcomes were closely monitored. Data will be analyzed at the end of study to obtain primary and secondary outcome.