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Abstract：
BACKGROUND: Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants.
OBJECTIVE: This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS.
METHODS: An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18.
RESULTS: Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05).
CONCLUSIONS: These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes.
BACKGROUND: The study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view .
UNASSIGNED: 28/02/2021.
UNASSIGNED: DATA SET: This research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint .
OBJECTIVE: This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS.
METHODS: An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18.
RESULTS: Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05).
CONCLUSIONS: These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes.
BACKGROUND: The study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view .
UNASSIGNED: 28/02/2021.
UNASSIGNED: DATA SET: This research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint .
摘要：
背景：呼吸窘迫综合征（RDS）是早产儿中最重要和最常见的疾病之一。
目的：本研究旨在比较表面活性剂和布地奈德与表面活性剂单独联合治疗对RDS早产儿支气管肺发育不良（BPD）和死亡率的影响。
方法：对在阿亚图拉穆萨维医院出生的134名RDS早产儿进行了一项结局评估盲随机临床试验，Zanjan,2021年伊朗。使用协变量自适应随机化方法将参与者分为两组（单独的表面活性剂以及表面活性剂和布地奈德的组合）。主要结果是从入院到出院的BPD和死亡率。本研究中的数据使用SPSS软件版本18进行分析。
结果：两组之间死亡率和BPD的总体比较没有显着差异（p>0.05）。亚组结果显示，与单独使用表面活性剂相比，向30周龄以下的婴儿施用表面活性剂与布地奈德显著减少了死亡人数(5vs.17).肺出血的发生也观察到了类似的积极作用，需要第二剂表面活性剂，氧指数,34周龄以下婴儿的平均血压和平均动脉压（MAP）与超过34周龄的婴儿相比（p<0.05）。
结论：这些研究结果表明，表面活性剂和布地奈德联合治疗可能是有益的，特别是小于34周胎龄和1500出生体重的早产儿。然而,需要更多样本量和更长随访时间的进一步研究来确认这些结果并评估长期结局.
背景：该研究在伊朗临床试验注册网站注册，代码为IRCT20201222049802N1。https://en.irct.ir/用户/试用版/48117/视图。
■2021年2月28日。
■数据集：此研究数据集链接显示在Zanjan-IranMedicalSciences网站上：https://存储库。zums.AC.ir/cgi/users/login?target=https%3A%2F/repository。zums.AC.ir/id/eprint。
目的：本研究旨在比较表面活性剂和布地奈德与表面活性剂单独联合治疗对RDS早产儿支气管肺发育不良（BPD）和死亡率的影响。
方法：对在阿亚图拉穆萨维医院出生的134名RDS早产儿进行了一项结局评估盲随机临床试验，Zanjan,2021年伊朗。使用协变量自适应随机化方法将参与者分为两组（单独的表面活性剂以及表面活性剂和布地奈德的组合）。主要结果是从入院到出院的BPD和死亡率。本研究中的数据使用SPSS软件版本18进行分析。
结果：两组之间死亡率和BPD的总体比较没有显着差异（p>0.05）。亚组结果显示，与单独使用表面活性剂相比，向30周龄以下的婴儿施用表面活性剂与布地奈德显著减少了死亡人数(5vs.17).肺出血的发生也观察到了类似的积极作用，需要第二剂表面活性剂，氧指数,34周龄以下婴儿的平均血压和平均动脉压（MAP）与超过34周龄的婴儿相比（p<0.05）。
结论：这些研究结果表明，表面活性剂和布地奈德联合治疗可能是有益的，特别是小于34周胎龄和1500出生体重的早产儿。然而,需要更多样本量和更长随访时间的进一步研究来确认这些结果并评估长期结局.
背景：该研究在伊朗临床试验注册网站注册，代码为IRCT20201222049802N1。https://en.irct.ir/用户/试用版/48117/视图。
■2021年2月28日。
■数据集：此研究数据集链接显示在Zanjan-IranMedicalSciences网站上：https://存储库。zums.AC.ir/cgi/users/login?target=https%3A%2F/repository。zums.AC.ir/id/eprint。
