Comparison of the Efficacy of Three Natural Surfactants (Curosurf, Survanta, and Alveofact) in the Treatment of Respiratory Distress Syndrome Among Neonates: A Randomized Controlled Trial

比较三种天然表面活性剂(Curosurf、Survanta 和 Alveofact)治疗新生儿呼吸窘迫综合征的疗效:一项随机对照试验

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Abstract

BACKGROUND: Although several different types of natural surfactants are available, including Alveofact, Curosurf, and Survanta, the preferred type and the magnitude of their effects are unknown. OBJECTIVES: This study was designed to compare the effects of these three surfactants on the gas exchange and clinical outcomes of neonates with respiratory distress syndrome (RDS). METHODS: This triple-blind randomized clinical trial studied all preterm neonates ≤ 37 weeks with RDS who were admitted to the neonatal intensive care unit (NICU) of Taleghani hospital (Tabriz, Iran) between 2012 and 2013. The patients were divided into three groups, each of which received one of these surfactants. The incidences of ventilator dependency, patent ductus arteriosus (PDA), broncho-pulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), hospital-stay length, and continuous positive airway pressure (CPAP) failure, as well as blood gas levels, were recorded as endpoint measurements and compared. RESULTS: In total, 165 neonates of gestational age ≤ 37 weeks with RDS were examined. Neonates were allocated to three different groups randomly, including a Survanta group (n = 49), a Curosurf group (n = 62), and an Alveofact group (n = 54). The mean gestational age of the neonates was 31.6 ± 3.7 weeks, and their mean weight was 1,840 ± 790 grams. The male/female ratio was 2:1 (67% male, 33% female); 104 (63%) neonates were ≤ 32 weeks gestational age, and 61 (37%) were >32 weeks. There were no significant differences for gender or demographic characteristics among the neonates in relation to the type of applied surfactant. According to the clinical parameters (BPD, IVH, ROP, hospital-stay length, and mechanical ventilation requirement), no significant differences were observed between the groups before and after surfactant administration, but the differences between the Survanta and Alveofact groups for the incidence rates of pneumothorax (P = 0.03) and pulmonary hemorrhage (P = 0.03) were statistically significant. CONCLUSIONS: No significant differences were observed in most of the clinical variables between the three types of natural surfactant, but in neonates ≤ 32 weeks, the incidence of pneumothorax was significantly higher in the Alveofact group; in neonates > 32 weeks, the incidences of PDA, mean hospital-stay length, and mean mechanical ventilation time were also significantly higher in the same group. It thus appears that Curosurf and Survanta replacement therapies among premature neonates with RDS perform better than Alveofact replacement therapy.

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