Rezaei Mehrdad, Abbasi Batool, Najib Khadijehsadat, Ardakani Seyed Mostajab Razavinezhad, Moghtaderi Mozhgan, Mostafavi Sara
Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Oman Med J. 2025 Mar 31;40(2):e730. doi: 10.5001/omj.2025.55. eCollection 2025 Mar.
Surfactant therapy is an established treatment for neonatal respiratory distress syndrome (RDS). We sought to compare two administration techniques, intubation-surfactant administration-extubation (INSURE) and minimally invasive surfactant therapy (MIST), for efficacy and safety in premature neonates with RDS.
In this randomized clinical trial, premature neonates with RDS admitted to a neonatal intensive care unit in Iran from July to December 2020 were randomly assigned either to INSURE or MIST. In the MIST group, the surfactant was administered during spontaneous breathing via a thin vascular catheter without intubation. In the INSURE group, infants were intubated, surfactant administered, and then extubated. The key outcomes were the frequency of surfactant administration, duration of oxygen support, need for mechanical ventilation in the first 72 hours, and complications arising.
The baseline characteristics of the studied premature neonates (N = 82) were similar between the INSURE (n = 44) and MIST (n = 38) groups. The surfactant treatment time was much shorter for the INSURE group (10.5 ± 17.0 minutes) than for the MIST group (42.0 ± 42.5 minutes; < 0.001). All infants received the first dose of surfactant, and requiring a second dose was obeserved in 17 (38.6%) in the INSURE group and 18 (47.4%) in the MIST group ( 0.400). There were no significant differences between the groups in the incidence of intraventricular hemorrhage, bronchopulmonary dysplasia, patent ductus arteriosus, pneumothorax, pulmonary hemorrhage, or disseminated intravascular coagulation. The duration of nasal continuous positive airway pressure and the need for mechanical ventilation were also similar.
Both INSURE and MIST techniques are effective and safe for administering surfactant therapy to premature infants with RDS, with no significant differences in outcomes or complications.
表面活性剂疗法是治疗新生儿呼吸窘迫综合征（RDS）的既定疗法。我们试图比较两种给药技术，即插管-表面活性剂给药-拔管（INSURE）和微创表面活性剂疗法（MIST），用于患有RDS的早产儿的疗效和安全性。
在这项随机临床试验中，2020年7月至12月入住伊朗一家新生儿重症监护病房的患有RDS的早产儿被随机分配至INSURE组或MIST组。在MIST组中，表面活性剂通过细血管导管在自主呼吸时给药，无需插管。在INSURE组中，婴儿先插管，给予表面活性剂，然后拔管。主要结局包括表面活性剂给药频率、氧支持持续时间、头72小时内机械通气需求以及出现的并发症。
所研究的早产儿（N = 82）的基线特征在INSURE组（n = 44）和MIST组（n = 38）之间相似。INSURE组的表面活性剂治疗时间（10.5±17.0分钟）比MIST组（42.0±42.5分钟；P<0.001）短得多。所有婴儿均接受了第一剂表面活性剂，INSURE组有17例（38.6%）、MIST组有18例（47.4%）需要第二剂表面活性剂（P = 0.400）。两组在脑室内出血、支气管肺发育不良、动脉导管未闭、气胸、肺出血或弥散性血管内凝血的发生率方面无显著差异。鼻持续气道正压通气的持续时间和机械通气需求也相似。
INSURE和MIST技术在给患有RDS的早产儿进行表面活性剂治疗时均有效且安全，在结局或并发症方面无显著差异。
