Objective To evaluate the safety of an aerosolised surfactant, SF-RI 1, administered via nasal continuous positive airway pressure (nCPAP) and a prototype breath synchronisation device (AeroFact), to preterm infants with respiratory distress syndrome (RDS). Design Multicentre, open-label, dose-escalation study with historical controls. Setting Newborn intensive care units at Mater Mothers’ Hospital, Brisbane, and Royal Hospital for Women, Sydney, Australia. Patients Infants 26 weeks through 30 weeks gestation who required nCPAP 6–8 cmH2O and fraction of inspired oxygen (FiO2) <0.30 at <2 hours of age. Interventions In part 1, infants received a single dose of 216 mg/kg of aerosolised surfactant. In part 2, infants could receive up to four doses of aerosolised surfactant. Three historical control infants were matched for each enrolled infant. Main outcome measures Treatment failure was defined as Respiratory Severity Score (FiO2×cmH2O nCPAP) >2.4, nCPAP >8 cmH2O, arterial carbon dioxide >65 mm Hg, pH <7.20 or three severe apnoeas within 6 hours during the first 72 hours of life. Other outcomes included tolerance of the AeroFact treatment and complications of prematurity. Results 10 infants were enrolled in part 1 and 21 in part 2 and were compared with 93 historical controls. No safety issues were identified. In part 2, 6 of 21 (29%) AeroFact-treated infants compared with 30 of 63 (48%) control infants met failure criteria. Kaplan-Meier analysis of patients in part 2 showed a trend towards decreased rate of study failure in the AeroFact-treated infants compared with historical controls (p=0.10). Conclusion The AeroFact system can safely deliver aerosolised surfactant to preterm infants with RDS who are on nCPAP. Trial registration number ACTRN12617001458325. Data are available upon reasonable request. Data not included in the article text may be available for subsequent meta-analysis. Please contact the corresponding author for details.

中文翻译：

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雾化表面活性剂治疗早产儿呼吸窘迫综合征的试验

目的评估通过鼻腔持续气道正压通气 (nCPAP) 和原型呼吸同步装置 (AeroFact) 给药的雾化表面活性剂 SF-RI 1 对患有呼吸窘迫综合征 (RDS) 的早产儿的安全性。设计具有历史对照的多中心、开放标签、剂量递增研究。在布里斯班的 Mater Mothers' Hospital 和澳大利亚悉尼的 Royal Hospital for Women 设置新生儿重症监护室。患者 妊娠 26 周至 30 周需要 nCPAP 6-8 cmH2O 和吸入氧分数 (FiO2) <0.30 且小于 2 小时的婴儿。干预 在第 1 部分中，婴儿接受了单剂量 216 毫克/千克的雾化表面活性剂。在第 2 部分中，婴儿最多可以接受四剂雾化表面活性剂。每个登记婴儿匹配三个历史对照婴儿。主要结局指标 治疗失败定义为呼吸严重程度评分 (FiO2×cmH2O nCPAP) >2.4、nCPAP >8 cmH2O、动脉二氧化碳 >65 mm Hg、pH <7.20 或在生命的前 72 小时内 6 小时内出现 3 次严重呼吸暂停. 其他结果包括对 AeroFact 治疗的耐受性和早产并发症。结果 第 1 部分招募了 10 名婴儿，第 2 部分招募了 21 名婴儿，并与 93 名历史对照组进行了比较。没有发现安全问题。在第 2 部分中，21 名 (29%) 接受 AeroFact 治疗的婴儿中有 6 名符合失败标准，而 63 名 (48%) 对照婴儿中有 30 名符合失败标准。第 2 部分中患者的 Kaplan-Meier 分析显示，与历史对照相比，AeroFact 治疗的婴儿的研究失败率有降低的趋势 (p=0.10)。结论 AeroFact 系统可以安全地向使用 nCPAP 的 RDS 早产儿输送雾化表面活性剂。试用注册号 ACTRN12617001458325。可应合理要求提供数据。文章正文中未包含的数据可用于后续的荟萃分析。详情请联系通讯作者。