Respiratory distress syndrome of newborn. Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention 1: Intervention group: Hospitalized neonates receive Beraksurf vial at a dose of 4 cc per kilogram by intratracheal method. Beraksurf is a natural surfactant. Each vial of Beraksurf (Bera
Sponsors
Zanjan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 1 Months
Inclusion criteria
Inclusion criteria: Neonates with a gestational age less than or equal to 34 weeks Neonates who were not intubated at birth Neonates who are on non-invasive respiratory support at birth Moderate or severe respiratory distress FIO2 requirement greater than 40% need surfactant injection
Exclusion criteria
Exclusion criteria: Congenital abnormalities Congenital structural pulmonary disease Congenital heart disease neonates who underwent advanced resuscitation at birth neonates who were intubated due to severe respiratory distress at birth neonates with a gestational age of less than 26 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The need for intubation in the first 72 hours of birth. Timepoint: The first 72 hours of birth. Method of measurement: Record patient file information. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Pneumothorax. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray.;Duration requires Mechanical ventilation. Timepoint: From patient admission to hospital discharge. Method of measurement: Count the days required for a mechanical ventilation.;Incidence of pulmonary hemorrhage. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray.;Incidence of Intraventricular hemorrhage. Timepoint: At 7, 14 and 30 days if hospitalized. Method of measurement: Brain Sonography.;Need the next dose of Surfactant. Timepoint: The first three days of hospitalization. Method of measurement: Record patient file information.;Incidence of death. Timepoint: Incidence of death from admission to hospital discharge. Method of measurement: Physical examination.;Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: Count the number of hospitalization days.;Duration of need for non-invasive ventilation. Timepoint: From patient admission to hospital discharge. Method of measurement: Number of days required for non-invasive ventilation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsghar Marzban
Zanjan University of Medical Sciences
Outcome results
None listed