Clinical trial of Varasurf compared with Curosurf

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 119

Inclusion Criteria

Premature neonate with respiratory distress syndrome based on physician's diagnosis
Born with gestational age of 28 to 34 weeks in the location of study site
With birth weight between 1000 and 2500 grams
Study enrollment and receiving the first dose of surfactant up to 6 hours after birth
The need for fraction of inspired oxygen (FIO2) more than 30% to maintain saturation of peripheral oxygen (SPO2) 90-94%
Failure of early nasal continuous positive airway pressure (CPAP) immediately after birth
Signing the informed consent form by the parent or legal guardian of the neonate

Exclusion Criteria

Moderate to severe asphyxia at birth (Apgar Score 5- and 10-minute, less than 5 or the need for continuous resuscitation 10 minutes after the birth of the neonate, or umbilical cord arterial blood gas (ABG) result with pH less than 7)
Neonatal encephalopathy
Receiving any type of surfactant by neonates before the study enrollment
Diagnosis of major congenital anomalies (congenital cardiac anomalies, life-threatening anomalies, respiratory failure due to causes other than RDS, and chromosomal abnormalities)
Presence of pulmonary hemorrhage and pneumothorax before the study enrollment
Simultaneous participation of the neonate in other clinical trials
The neonate's need for surgical procedures
The need for invasive mechanical ventilation of the neonates before study enrollment or before administration of surfactant (phase I only)
Neonatal hypoglycemia (plasma glucose concentration lower than 50 mg/dl with a glucometer)
History of mother's addiction to alcohol or drugs
Diagnosis of maternal chorioamnionitis
History of neonatal convulsions
Presence of meconium aspiration in neonate
Rupture of membrane more than 18 hours

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The area under the curve of the need for fraction of inspired oxygen. Timepoint: Immediately before the administration of surfactant until 6 hours (0, 0.25, 0.5, 1, 2, 3, 4, 5 and 6 hours) after the administration of the first surfactant. Method of measurement: Fraction of inspired oxygen recording.;Duration of respiratory support need (invasive and non-invasive mechanical ventilation). Timepoint: Up to 28 days after receiving the first dose of surfactant. Method of measurement: Day.

Secondary Outcome Measures