A clinical trial to study the effect of adding magnesium sulphate (IV) in children not responding to conventional treatment of bronchiolitis.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Bronchiolitis
- Registration Number
- CTRI/2013/04/003556
- Lead Sponsor
- Deptt of Pediatrics Lady Hardinge Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 1.Proportion of children achieving Improved Respiratory Status at 48 hours. <br/ ><br>2.Time taken for a shift in categories of respiratory distress from severe to moderate and moderate to mild. <br/ ><br>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.) <br/ ><br>4.Duration of hospital stay and of oxygen therapy. <br/ ><br>Timepoint: Composite score shall be assessed at admission, at 1, 3, 6, 12, 24, 48, 72 hours and at discharge.