A clinical trial to study the effect of adding magnesium sulphate (IV) in children not responding to conventional treatment of bronchiolitis.

Add-on use of magnesium sulphate in children with bronchiolitis - ADIVMAG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/04/003556

Enrollment

Registered

2013-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Bronchiolitis

Interventions

Intervention1: IV Magnesium Sulfate: Enrolled cases in the intervention group shall be given 40mg/kg intravenous magnesium sulfate diluted in about 20-30ml of NS over 30 minutes. Those who continue t

Eligibility

Inclusion criteria

Inclusion criteria: • First or second episode of bronchiolitis. WITH • Moderate to severe disease (composite score 15 or more) after initial therapy with nebulized epinephrine.

Exclusion criteria

Exclusion criteria: 1.Presence of clinical evidence of Heart Disease 2.Chronic lung disease 3.Patients with the requirement of mechanical ventilation initially. 4. Children with neurological conditions like Cerebral Palsy, Global Developmental Delay, post meningitic or enchephalitic sequale. 5.Premature birth (defined as birth before 36 weeks of gestation). 6.Immunosuppression or immunodeficiency or treatment with corticosteroids in the previous 14 days.

Design outcomes

Primary

Measure	Time frame
The proportion of children achieving Improved Respiratory Status at the end of first 24 hours of treatment. Improved Respiratory Status shall be objectively defined as an improvement in the composite scores large enough to shift a patient from severe to moderate or lesser scores or from moderate to mild scores over time.Timepoint: composite score shall be assessed at admission, at 1, 3, 6, 12, 24, 48, 72 hours and at discharge.	—

Measure

Time frame

The proportion of children achieving Improved Respiratory Status at the end of first 24 hours of treatment. Improved Respiratory Status shall be objectively defined as an improvement in the composite scores large enough to shift a patient from severe to moderate or lesser scores or from moderate to mild scores over time.Timepoint: composite score shall be assessed at admission, at 1, 3, 6, 12, 24, 48, 72 hours and at discharge.

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Secondary

Measure	Time frame
1.Proportion of children achieving Improved Respiratory Status at 48 hours. 2.Time taken for a shift in categories of respiratory distress from severe to moderate and moderate to mild. 3.Failure (defined as upward shift in categories from mild to moderate or moderate to severe, worsening of clinical score in severe cases as well as requirement of ICU admission or mechanical ventilation, worsening of oxygen saturation.) 4.Duration of hospital stay and of oxygen therapy. Timepoint: Composite score shall be assessed at admission, at 1, 3, 6, 12, 24, 48, 72 hours and at discharge.	—

Measure

Time frame

1.Proportion of children achieving Improved Respiratory Status at 48 hours. 2.Time taken for a shift in categories of respiratory distress from severe to moderate and moderate to mild. 3.Failure (defined as upward shift in categories from mild to moderate or moderate to severe, worsening of clinical score in severe cases as well as requirement of ICU admission or mechanical ventilation, worsening of oxygen saturation.) 4.Duration of hospital stay and of oxygen therapy. Timepoint: Composite score shall be assessed at admission, at 1, 3, 6, 12, 24, 48, 72 hours and at discharge.

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Countries

India

Contacts

Public ContactVarinder Singh

Lady Hardinge Medical College and assoc Kalawati Saran Childrens Hospital

sukritigupta87@gmail.com9899644661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026