Early inhaled nitric oxide therapy in premature newborns with respiratory failure
Early inhaled nitric oxide therapy in premature newborns with respiratory failure
复制标题
DOI：
10.1056/nejmoa060442
复制
发表时间：
2006-07-27
影响因子：
158.5
通讯作者：
Abman, Steven H.
中科院分区：
文献类型：
--
作者：
Kinsella, John P.;Cutter, Gary R.;Abman, Steven H.
背景资料：早产儿呼吸衰竭早期，低剂量，长期吸入一氧化氮治疗的安全性和有效性尚不确定。方法：我们进行了一项多中心，随机试验，涉及793名新生儿谁是34周或更少的胎龄和呼吸衰竭需要机械通气。新生儿被随机分配接受吸入一氧化氮（5 ppm）或安慰剂气体21天或直至拔管，根据出生体重分层（500至749 g，750至999 g或1000至1250 g）。主要疗效结局为经后36周时死亡或支气管肺发育不良的复合终点。次要安全性结果包括严重颅内出血、脑室周围白质软化和脑室扩大。结果：总的来说，吸入一氧化氮组和安慰剂组的死亡或支气管肺发育不良发生率无显著差异（71.6%比75.3%，P=0.24）。然而，对于出生体重在1000和1250 g之间的婴儿，与安慰剂相比，吸入一氧化氮治疗降低了支气管肺发育不良的发生率（29.8%对59.6%）;对于整个队列，这种治疗降低了颅内出血、脑室周围白质软化或脑室扩大的联合终点（17.5%对23.9%，P=0.03）和单独的脑室周围白质软化（5.2%对9.0%，P=0.048）。吸入一氧化氮治疗并没有增加肺出血或其他不良事件的发生率。结论：在早产儿呼吸衰竭，低剂量吸入一氧化氮并没有降低支气管肺发育不良的总体发病率，除了在婴儿出生体重至少1000克，但它确实降低了脑损伤的总体风险。（ClinicalTrials.gov编号，NCT 00006401。）
Background: The safety and efficacy of early, low-dose, prolonged therapy with inhaled nitric oxide in premature newborns with respiratory failure are uncertain.Methods: We performed a multicenter, randomized trial involving 793 newborns who were 34 weeks of gestational age or less and had respiratory failure requiring mechanical ventilation. Newborns were randomly assigned to receive either inhaled nitric oxide (5 ppm) or placebo gas for 21 days or until extubation, with stratification according to birth weight (500 to 749 g, 750 to 999 g, or 1000 to 1250 g). The primary efficacy outcome was a composite of death or bronchopulmonary dysplasia at 36 weeks of postmenstrual age. Secondary safety outcomes included severe intracranial hemorrhage, periventricular leukomalacia, and ventriculomegaly.Results: Overall, there was no significant difference in the incidence of death or bronchopulmonary dysplasia between patients receiving inhaled nitric oxide and those receiving placebo (71.6 percent vs. 75.3 percent, P=0.24). However, for infants with a birth weight between 1000 and 1250 g, as compared with placebo, inhaled nitric oxide therapy reduced the incidence of bronchopulmonary dysplasia (29.8 percent vs. 59.6 percent); for the cohort overall, such treatment reduced the combined end point of intracranial hemorrhage, periventricular leukomalacia, or ventriculomegaly (17.5 percent vs. 23.9 percent, P=0.03) and of periventricular leukomalacia alone (5.2 percent vs. 9.0 percent, P=0.048). Inhaled nitric oxide therapy did not increase the incidence of pulmonary hemorrhage or other adverse events.Conclusions: Among premature newborns with respiratory failure, low-dose inhaled nitric oxide did not reduce the overall incidence of bronchopulmonary dysplasia, except among infants with a birth weight of at least 1000 g, but it did reduce the overall risk of brain injury. (ClinicalTrials.gov number, NCT00006401.)