Role of intravenous Magnesium Sulphate in moderate to severe Bronchiolitis

Intravenous Magnesium Sulphate Versus Placebo in clinical recovery time in moderate to severe Bronchiolitis :A Double Blind Randomized Controlled Trial - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095919

Enrollment

Registered

2025-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J20-J22- Other acute lower respiratory infections

Interventions

Intervention1: 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 const

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Secondary

Measure	Time frame
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.Timepoint: 1- 14 days	—

Measure

Time frame

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.Timepoint: 1- 14 days

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Countries

India

Contacts

Public ContactDr Tushar Jagzape

All India Institute of Medical Science , Raipur

tusharjagzape@aiimsraipur.edu.in9421783796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026