Inhaled nitric oxide in preterm infants undergoing mechanical ventilation
Inhaled nitric oxide in preterm infants undergoing mechanical ventilation
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DOI：
10.1056/nejmoa061088
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发表时间：
2006-07-27
影响因子：
158.5
通讯作者：
Coburn, Christine E.
中科院分区：
文献类型：
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作者：
Ballard, Roberta A.;Truog, William E.;Coburn, Christine E.
背景资料：早产儿支气管肺发育不良与住院时间延长以及肺部和神经发育异常有关。在动物模型中，吸入一氧化氮可改善气体交换和肺结构发育，但在有支气管肺发育不良风险的婴儿中使用这种疗法存在争议。方法：我们进行了一项随机，分层，双盲，安慰剂-在21个中心进行的吸入一氧化氮对照试验，涉及出生体重为1250 g或更低的婴儿，这些婴儿在7 - 21天内需要辅助支持年龄。接受治疗的婴儿接受浓度递减的一氧化氮，从20 ppm开始，至少24天。主要结果是生存无支气管肺发育不良在36周postmenstrual age.Results：在294名婴儿接受一氧化氮和288名接受安慰剂出生体重（分别为766克和759克），胎龄（26周，两组），和其他特征是相似的。经后36周时无支气管肺发育不良的存活率在一氧化氮组为43.9%，安慰剂组为36.8%（P=0.042）。吸入一氧化氮组患儿出院时间较早（P=0.04），辅助供氧时间较短（P=0.006）。有没有短期safety concerns.Conclusions：吸入一氧化氮治疗改善肺的早产儿谁是在支气管肺发育不良的风险时，它是在7和21天的年龄之间开始，并没有明显的短期不良反应的结果。（ClinicalTrials.gov编号，NCT 00000548。）
Background: Bronchopulmonary dysplasia in premature infants is associated with prolonged hospitalization, as well as abnormal pulmonary and neurodevelopmental outcome. In animal models, inhaled nitric oxide improves both gas exchange and lung structural development, but the use of this therapy in infants at risk for bronchopulmonary dysplasia is controversial.Methods: We conducted a randomized, stratified, double-blind, placebo-controlled trial of inhaled nitric oxide at 21 centers involving infants with a birth weight of 1250 g or less who required ventilatory support between 7 and 21 days of age. Treated infants received decreasing concentrations of nitric oxide, beginning at 20 ppm, for a minimum of 24 days. The primary outcome was survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age.Results: Among 294 infants receiving nitric oxide and 288 receiving placebo birth weight (766 g and 759 g, respectively), gestational age (26 weeks in both groups), and other characteristics were similar. The rate of survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age was 43.9 percent in the group receiving nitric oxide and 36.8 percent in the placebo group (P=0.042). The infants who received inhaled nitric oxide were discharged sooner (P=0.04) and received supplemental oxygen therapy for a shorter time (P=0.006). There were no short-term safety concerns.Conclusions: Inhaled nitric oxide therapy improves the pulmonary outcome for premature infants who are at risk for bronchopulmonary dysplasia when it is started between 7 and 21 days of age and has no apparent short-term adverse effects. (ClinicalTrials.gov number, NCT00000548.)