Document Type : Original Article
Department of Pediatrics and Neonates, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran
Department of Community Medicine, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran
Background: The use of surfactants is still considered a cornerstone in the treatment of neonatal respiratory distress syndrome (RDS). This study aimed to compare two doses of Curosurf to determine the most effective dose of this medicine with the least side effects. The study was performed as a double-blind clinical trial in the Neonatal Intensive Care Unit of Valiasr Hospital in Birjand, Iran, from June to October 2021 on 51 neonates admitted with RDS.
Methods: Neonates with RDS who met the inclusion criteria were randomly divided into two groups. Initially, they underwent nasal Continuous Positive Air Way Pressure (n-CPAP), and if failed, Curosurf was administered intratracheally at a dose of 100 or 200 mg/kg. The two groups were compared in the mean hospital stay, the need for supplemental oxygen, the need for n-CPAP, the start of complementary feeding after Curosurf injection, the relative frequency of the need for mechanical ventilation, and possible complications after the injection and re-injection of surfactant. Data were analyzed using the independent sample t-test, the Mann–Whitney U test, Chi-squared test, and Fisher’s exact test at a significance level of α=0.05.
Results: The sample size was calculated based on the existing studies considering the days of the need for oxygen therapy in the two groups with different doses of surfactant (6.4±3.5 and 8.9±2.6 days) and according to the formula for comparing the means in the two groups with 95% confidence interval and 80% power. Accordingly, 24 neonates were assigned to each group. N=[z (1-α/2)+z (1-β)] (δ12+δ22)/ (µ1-µ2)2. Data were analyzed at a significant level of α=0.05. The findings indicated no significant difference between the two groups of neonates in the mean length of hospital stay, adjuvant oxygen requirement, n-CPAP requirement, time to oral feeding initiation from birth with breast milk (with breast or assistive devices) or formula, the relative frequency of the need for mechanical ventilation, and possible side effects after the injection and re-injection of surfactant.
Conclusion: In conclusion, 100 and 200 mg/kg of Curosurf appear to have the same effects and outcomes in the treatment of neonatal RDS.