A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure
A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure
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DOI：
10.1542/peds.113.3.559
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发表时间：
2004-03-01
期刊：
影响因子：
8
通讯作者：
Peliowski, A
中科院分区：
文献类型：
--
作者：
Konduri, GG;Solimano, A;Peliowski, A
目标。吸入一氧化氮(INO)减少了体外膜氧合(ECMO)的使用/患有严重缺氧性呼吸衰竭的足月儿和近月儿的死亡率。我们进行了一项随机、双盲、多中心试验，以确定呼吸衰竭早期应用iNO是否会进一步降低这些结果的发生率。在研究气体开始后，73%的早期iNO组和37%的对照组婴儿中，当他们需要辅助呼吸时，早产iNO组和对照组婴儿的氧合指数(OI)分别大于或等于15和20毫米汞柱。对照组婴儿接受标准iNO治疗，病情恶化至OI>；40的几率高于早期接受iNO治疗的婴儿。两组早期死亡(iNO，6.7%vs对照组9.4%)、体外循环术(10.7%vs 12.1%)及两者合并率(16.7%vs 19.5%)相似。在有呼吸衰竭的足月儿和近月儿中，INO改善了氧合，但不能降低ECMO/死亡率的发生率。
Objective. Inhaled nitric oxide (iNO) reduces the use of extracorporeal membrane oxygenation (ECMO)/incidence of death in term and near-term neonates with severe hypoxic respiratory failure. We conducted a randomized, double masked, multicenter trial to determine whether administration of iNO earlier in respiratory failure results in additional reduction in the incidence of these outcomes.Methods. Neonates who were born at greater than or equal to34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) greater than or equal to15 and 20 mm Hg in 73% of early iNO and 37% of control infants after study gas initiation. Control infants received standard iNO and deteriorated to OI >40 more often than infants who were given early iNO. The incidence of death (early iNO, 6.7% vs control, 9.4%), ECMO (10.7% vs 12.1%), and their combined incidence (16.7% vs 19.5%) were similar in both groups.Conclusion. iNO improves oxygenation but does not reduce the incidence of ECMO/mortality when initiated at an OI of 15 to 25 compared with initiation at >25 in term and near-term neonates with respiratory failure.