Multicenter controlled clinical trial of high-frequency jet ventilation in preterm infants with uncomplicated respiratory distress syndrome

Multicenter controlled clinical trial of high-frequency jet ventilation in preterm infants with uncomplicated respiratory distress syndrome
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DOI:
10.1542/peds.100.4.593
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发表时间:
1997-10-01
期刊:
影响因子:
8
通讯作者:
Davis, JM
Davis, JM
中科院分区:
医学2区
文献类型:
--
作者:
Keszler, M;Modanlou, HD;Davis, JM

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Objective.为了验证高频喷射通气(HFJV)将降低支气管肺发育不良(BPD)和急性漏气的发生率和/或严重程度的假设,尽管使用表面活性剂,早产儿仍需要机械通气治疗呼吸窘迫综合征。HFJV和常规通气(CV)的多中心、随机、对照临床试验。患者将继续接受指定治疗14天或直至拔管,以先发生者为准。如果发生双侧肺间质性肺气肿或支气管胸膜瘘,则允许从CV交叉至HFJV。如果符合失败标准,患者可以交叉到其他治疗模式。HFJV方案规定了最佳肺容量策略,以提供肺泡复张并优化肺容量和通气/灌注灌注匹配,同时最大限度地减少压力幅度和O-2需求。CV管理不受方案控制。设置。八个三级新生儿重症监护病房。出生体重在700和1500 g之间,胎龄0.30的早产儿在表面活性剂给药后2至12小时,在8小时龄时接受表面活性剂,
Objective. To test the hypothesis that high-frequency jet ventilation (HFJV) will reduce the incidence and/or severity of bronchopulmonary dysplasia (BPD) and acute airleak in premature infants who, despite surfactant administration, require mechanical ventilation for respiratory distress syndrome.Design. Multicenter, randomized, controlled clinical trial of HFJV and conventional ventilation (CV). Patients were to remain on assigned therapy for 14 days or until extubation, whichever came first. Crossover from CV to HFJV was allowed if bilateral pulmonary interstitial emphysema or bronchopleural fistula developed. Patients could cross over to the other ventilatory mode if failure criteria were met. The optimal lung volume strategy was mandated for HFJV by protocol to provide alveolar recruitment and optimize lung volume and ventilation/perfusion perfusion matching, while minimizing pressure amplitude and O-2 requirements. CV management was not controlled by protocol.Setting. Eight tertiary neonatal intensive care units.Patients. Preterm infants with birth weights between 700 and 1500 g and gestational age 0.30 at 2 to 12 hours after surfactant administration, received surfactant by 8 hours of age, were