Efficacy of inhaled budesonide for reducing oxygen requirement in neonates with respiratory distress
Not Applicable
- Conditions
- Health Condition 1: P229- Respiratory distress of newborn, unspecified
- Registration Number
- CTRI/2024/05/067736
- Lead Sponsor
- CMS and GTB Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All neonates (more than 34 weeks) up to 28 days of life with respiratory distress requiring an FiO2 more than 30 percent on day 4 of admission admitted in extra-mural NICU.
Exclusion Criteria
1.Neonates who have non respiratory cause of respiratory distress (including congenital heart disease, Severe birth asphyxia, Polycythemia, Hypoglycemia etc.)
2.Neonates with Visible Gross Congenital Anomalies.
3.Neonates requiring exogenous surfactant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean duration of oxygen requirementTimepoint: randomization to day of discharge
- Secondary Outcome Measures
Name Time Method Mean Downes scoreTimepoint: At enrollment and then every 12 hours till 72 hours of budesonide nebulization;Mean duration of NICU and hospital stayTimepoint: randomization to day of discharge;Proportion of patients expiredTimepoint: randomization to day of expiry