Administration of budesonide with surfactant and prevention of bronchopulmonary dysplasia
Phase 3
- Conditions
- Respiratory distress syndrome of newborn.Respiratory distress syndrome of newborn
- Registration Number
- IRCT20100512003915N20
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
gestation age 26-30 weeks
birth weight less than 1250 grams
respiratory distress syndrome
Exclusion Criteria
5 minute Apgar score less than 4
congenital heart disease except patent ductus arteriosus and atrial septal defect
necrotizing entrocololitis
major congenital anomalies, esophageal atresia, diaphragmatic hernia
chromosomal anomalies
shock
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reintubation in first 3 days after extubation. Timepoint: We evaluate the neonate immediately after intervention and daily till 3 days after intervention and extubation. Method of measurement: tracheal reintubation.;Need to second doses of surfactant. Timepoint: Daily till day 3 of birth and 3 days after intervention. Method of measurement: surfactant administration.;Bronchopulmonary dysplasia. Timepoint: Daily till 28 days after birth and day 28 after intervention. Method of measurement: need to supplemental oxygen.
- Secondary Outcome Measures
Name Time Method