Open randomised controlled trial of inhaled nitric oxide and early dexamethasone in high risk preterm infants

Open randomised controlled trial of inhaled nitric oxide and early dexamethasone in high risk preterm infants
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DOI:
10.1136/fn.77.3.f185
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发表时间:
1997-11-01
影响因子:
4.4
通讯作者:
Shaw, NJ
Shaw, NJ
中科院分区:
医学1区
文献类型:
--
作者:
Subhedar, NV;Ryan, SW;Shaw, NJ

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目的:确定吸入性一氧化氮(NO)和/或地塞米松治疗是否能降低高风险早产儿慢性肺病(CLD)和/或死亡的发生率。方法:在年龄96小时时招募妊娠32周以下的婴儿,如果他们被认为有发生CLD的高风险。使用因子设计将婴儿随机分配到四个治疗组之一:(1)吸入5-20百万分之一的一氧化氮72小时;(2) 0.5-1 mg/kg/d静脉注射地塞米松,连用6天;(三)两种药品混用;(4)延续传统管理。结果:随机抽取42例婴儿:10例婴儿单独吸入NO;单独使用地塞米松;10两种处理;11种治疗方法都没有。吸入一氧化氮治疗组和对照组(RR 1.05, 95% CI 0.84-1.25)、地塞米松治疗组和对照组(RR 0.95, 95% CI 0.79-1.18)的新生儿CLD和/或出院前死亡的总发生率均无差异。结论:96小时时,吸入NO或地塞米松均不能预防CLD或死亡。
Aim-To determine whether treatment with inhaled nitric oxide (NO) and/or dexamethasone reduces the incidence of chronic lung disease (CLD) and/or death in high risk preterm infants.Methods-Infants below 32, weeks of gestation were recruited at 96 hours of age if they were deemed to be at high risk of developing CLD. Infants were randomly assigned to one of four treatment groups using a factorial design: (1) 5-20 parts per million inhaled NO for 72 hours; (2) 0.5-1 mg/kg/day intravenous dexamethasone for 6 days; (3) both drugs together; (4) continued conventional management.Results-Forty two infants were randomised: 10 infants received inhaled NO alone; 11 dexamethasone alone; 10 both treatments; and 11 neither treatment. There was no difference in the combined incidence of CLD and/or death before discharge from hospital between either infants treated with inhaled NO and controls (RR 1.05, 95% CI 0.84-1.25), or those treated with dexamethasone and controls (RR 0.95, 95% CI 0.79-1.18).Conclusions-At 96 hours of age, neither treatment with inhaled NO nor dexamethasone prevented CLD or death.