Comparison of efficacy & safety of Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS)
Phase 3
Recruiting
- Conditions
- Respiratory Distress Syndrome (RDS).Respiratory distress syndrome of newbornP22.0
- Registration Number
- IRCT20200529047594N1
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Parents consent to participate study
premature neonates with a gestational age of less than 34 weeks
premature neonates with diagnosis of RDS and candidates for surfactant
A maximum of 8 hours have elapsed since the birth
Exclusion Criteria
No parents consent to participate study
Newborns with congenital heart diseases and other life threatening congenital anomalies.
Adverse drug effects
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improved outcomes in RDS. Timepoint: Before intervention and after intervention. Method of measurement: the need for mechanical ventilation, Venous Blood Gas.;Mortality. Timepoint: During the hospital stay. Method of measurement: Dead / alive.;Drug-related complications. Timepoint: During the hospital stay. Method of measurement: Yes/No.
- Secondary Outcome Measures
Name Time Method