Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome
- Conditions
- Respiratory distress syndrome.Respiratory distress syndrome of newborn
- Registration Number
- IRCT2015071017413N12
- Lead Sponsor
- Baqiyatallah University of Medical Sciences, Deputy of Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 112
Neonates were born with RDS diagnosis in Najmieh and Baqiyatallah hospitals; weight of 750 to 1750 gr; gestational age less than 35 weeks; O2 saturation 85% to 96%; signed informed consent by parents; and age = 6 hours at the time of randomization. Exclusion criteria: Congenital heart diseases and other life threatening congenital anomalies; respiratory failure due to other causes, 5 minute Apgar score = 3; proven fetal lung maturity profile from amniocentesis; prior treatment with exogenous surfactant; prolonged (= 3 weeks) rupture of membranes; untreated hypotension or hypoglycemia; use of high-frequency ventilation prior to first dose of surfactant; and severe grades of intra-ventricular hemorrhage (grades III or IV) prior to surfactant.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eeding second surfactant dose. Timepoint: 12 to 24 hours after the first surfactant dose. Method of measurement: Yes / No.;Hospital stay. Timepoint: At the time of discharge. Method of measurement: Days.;Mortality. Timepoint: During the hospital stay. Method of measurement: Dead / alive.;Needing nasal continuous positive airway pressure. Timepoint: During the hospital stay. Method of measurement: Yes / No.;Needing endotracheal tube. Timepoint: During the hospital stay. Method of measurement: Yes / No.;RDS-related complications. Timepoint: During the hospital stay. Method of measurement: Yes / No.
- Secondary Outcome Measures
Name Time Method