Respiratory distress syndrome. Respiratory distress syndrome of newborn
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Needing 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran