Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn
Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn
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DOI：
10.1016/s0022-3476(97)70124-0
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发表时间：
1997-07-01
影响因子：
5.1
通讯作者：
Abman, SH
中科院分区：
文献类型：
--
作者：
Kinsella, JP;Truog, WE;Abman, SH
背景：虽然吸入一氧化氮（iNO）会引起选择性肺血管舒张并改善患有持续性肺动脉高压的新生儿的氧合，但其效果是可变的。我们假设 (1) 对 iNO 治疗的反应取决于与新生儿持续性肺动脉高压 (PPHN) 相关的原发疾病，以及 (2) 高频振荡通气 (HFOV) 与 iNO 联合治疗对于单独治疗失败的患者有效。方法：为了确定 iNO 和 HFOV 在治疗严重 PPHN 中的相对作用，我们在一项随机、多中心临床试验中招募了 205 名新生儿。按主要疾病类别对患者进行分层：呼吸窘迫综合征（n = 70）、胎粪吸入综合征（n = 58）、特发性 PPHN 或肺发育不全（不包括先天性膈疝）（“其他”：n = 43）和先天性膈疝（n = 34）；然后，他们被随机分配接受 iNO 和常规通气治疗或不接受 iNO 的 HFOV 治疗。治疗失败（动脉氧分压 [PaO2]
Background: Although inhaled nitric oxide (iNO) causes selective pulmonary vasodilation and improves oxygenation in newborn infants with persistent pulmonary hypertension, its effects are variable. We hypothesized (1) that the response to iNO therapy is dependent on the primary disease associated with persistent pulmonary hypertension of the newborn (PPHN) and (2) that the combination of high-frequency oscillatory ventilation (HFOV) with iNO would be efficacious in patients for whom either therapy alone had failed.Methods: To determine the relative roles of iNO and HFOV in the treatment of severe PPHN, we enrolled 205 neonates in a randomized, multicenter clinical trial. Patients were stratified by predominant disease category: respiratory distress syndrome (n = 70), meconium aspiration syndrome (n = 58), idiopathic PPHN or pulmonary hypoplasia (excluding congenital diaphragmatic hernia) (''other'': n = 43), and congenital diaphragmatic hernia (n = 34); they were then randomly assigned to treatment with iNO and conventional ventilation or to HFOV without iNO. Treatment failure (partial pressure of arterial oxygen [PaO2]