产房内持续肺膨胀治疗高危呼吸窘迫综合征早产儿（SLI 研究）：一项随机对照试验的研究方案。
Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial.
机构信息
Department of Surgical and Medical Critical Care, Section of Neonatology, Careggi University Hospital, Viale Morgagni 85, Florence 50141, Italy.
出版信息
Trials. 2013 Mar 8;14:67. doi: 10.1186/1745-6215-14-67.
BACKGROUND
Some studies have suggested that the early sustained lung inflation (SLI) procedure is effective in decreasing the need for mechanical ventilation (MV) and improving respiratory outcome in preterm infants. We planned the present randomized controlled trial to confirm or refute these findings.
METHODS/DESIGN: In this study, 276 infants born at 25(+0) to 28(+6) weeks' gestation at high risk of respiratory distress syndrome (RDS) will be randomized to receive the SLI maneuver (25 cmH2O for 15 seconds) followed by nasal continuous positive airway pressure (NCPAP) or NCPAP alone in the delivery room. SLI and NCPAP will be delivered using a neonatal mask and a T-piece ventilator.The primary endpoint is the need for MV in the first 72 hours of life. The secondary endpoints include the need and duration of respiratory support (NCPAP, MV and surfactant), and the occurrence of bronchopulmonary dysplasia (BPD).
TRIAL REGISTRATION NUMBER
NCT01440868.
背景
一些研究表明，早期持续肺膨胀（SLI）程序可有效降低早产儿机械通气（MV）的需求，并改善呼吸结局。我们计划进行本次随机对照试验，以证实或反驳这些发现。
方法/设计：本研究纳入了 276 名 25（+0）至 28（+6）周胎龄、有发生呼吸窘迫综合征（RDS）风险的高危早产儿，将其随机分为 SLI 组（25 cmH2O 持续 15 秒）和对照组（NCPAP 组），在产房接受治疗。SLI 和 NCPAP 将通过新生儿面罩和 T 型管通气器给予。主要终点为出生后 72 小时内需要 MV 的情况。次要终点包括呼吸支持（NCPAP、MV 和表面活性剂）的需要和持续时间，以及支气管肺发育不良（BPD）的发生情况。
试验注册号
NCT01440868。
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