Investigation of the safety and efficacy of Varasurf (ovine pulmonary surfactant, produced by Artiman Pharmed Alborz company) compared to Curosurf (porcine pulmonary surfactant produced by Chiesi company) in premature neonates with gestational ages between 28 and 34 weeks with respiratory distress syndrome (RDS)

Artiman Pharmed Alborz0 个研究点目标入组 119 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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

•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

发起方

Artiman Pharmed Alborz