Health Condition 1: J479- Bronchiectasis, uncomplicated
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children 5-18 years of age, diagnosed with Cystic fibrosis, on regular chest physiotherapy for at least 3 months
Exclusion criteria
Exclusion criteria: Children with history of adverse reaction to hypertonic saline or sodium bicarbonate, or history of exposure to inhaled sodium bicarbonate in preceding 3 months, or having acute severe exacerbation at the time of screening or very severe pulmonary dysfunction (FEV1 less than 30% predicted) or inability to perform spirometry or home oxygen therapy at the time of screening or within preceding 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare changes in pulmonary function (FEV1) following 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on adverse effectsTimepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Ease of sputum expectorationTimepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Frequency of Pulmonary exacerbations requiring hospitalization or i/v or oral antibiotic use.Timepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Clinical severity score using Modified N. Huang Clinical Severity ScoreTimepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Airway colonization with respiratory pathogens commonly colonizing airway in CFTimepoint: 3 months | — |
Countries
India
Contacts
All Delhi