INSURE in Neonatal Respiratory Distress Syndrome. Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention 1: control group: intubation, surfactant replacemnt therapy, extubation to NCPAP. Intervention 2: Case group: intubation, surfactant replacemnt therapy, extubation to HFNC.
Treatment - Drugs
control group: intubation, surfactant replacemnt therapy, extubation to NCPAP
Case group: intubation, surfactant replacemnt therapy, extubation to HFNC
Sponsors
Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 28 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: preterm infants with respiratory distress; need for surfactant therapy; gestational age 28-34 wks; parental written consent. Exclusion criteria: babies with major congenital anomalies; congenital heart disease; asphyxia with apgar score less than 5 in 5 minutes.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reintubation. Timepoint: after intervention till 3 days. Method of measurement: ABG assessment and RDS score and FIO2 requirment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of oxygen therapy. Timepoint: after intervention till discharge. Method of measurement: day.;Amount of oxygen therapy. Timepoint: after intervention. Method of measurement: fraction of oxygen.;Survival. Timepoint: after intervention till discharge. Method of measurement: alive or death. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahin Nariman MD
Tehran University of Medical Sciences
Outcome results
None listed