Prophylactic nasal continuous positive airways pressure in newborns of 28-31 weeks gestation: multicentre randomised controlled clinical trial
Prophylactic nasal continuous positive airways pressure in newborns of 28-31 weeks gestation: multicentre randomised controlled clinical trial
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DOI：
10.1136/adc.2003.037010
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发表时间：
2004-09-01
影响因子：
4.4
通讯作者：
Mosca, F
中科院分区：
文献类型：
--
作者：
Sandri, F;Ancora, G;Mosca, F
背景资料：经鼻持续气道正压通气（nCPAP）在早产儿呼吸窘迫综合征治疗中的作用尚未完全确定。目的：评价28-31周妊娠婴儿预防性nCPAP的获益和风险。设计：多中心随机对照临床试验。设置：17个意大利新生儿重症监护室。患者：共230名新生儿的28-31周的妊娠，没有插管在产房和没有重大畸形，被随机分配到预防性或救援nCPAP.Interventions：预防性nCPAP开始在30分钟内出生，无论氧气需求和临床状态。当FIO 2要求>0.4时，开始急救nCPAP，持续30分钟以上，以维持经皮氧饱和度在93%和96%之间。当nCPAP中FIO 2要求>0.4且存在呼吸窘迫综合征的放射学体征时，给予外源性表面活性剂。主要结局指标：主要终点：需要外源性表面活性剂。次要终点：结果：预防组和抢救组肺表面活性物质的使用率分别为22.6%和21.7%。预防组和急救组均有12.2%的患者需要机械通气。两组的漏气发生率均为2.6%。超过80%的两组接受产前steroids.Conclusions：在新生儿的28-31周妊娠，有没有更大的好处，在给予预防性nCPAP比在开始nCPAP时，氧气需求增加到FIO 2>0.4。
Background: The role of nasal continuous positive airways pressure (nCPAP) in the management of respiratory distress syndrome in preterm infants is not completely defined.Objective: To evaluate the benefits and risks of prophylactic nCPAP in infants of 28-31 weeks gestation.Design: Multicentre randomised controlled clinical trial.Setting: Seventeen Italian neonatal intensive care units.Patients: A total of 230 newborns of 28-31 weeks gestation, not intubated in the delivery room and without major malformations, were randomly assigned to prophylactic or rescue nCPAP.Interventions: Prophylactic nCPAP was started within 30 minutes of birth, irrespective of oxygen requirement and clinical status. Rescue nCPAP was started when FIO2 requirement was >0.4, for more than 30 minutes, to maintain transcutaneous oxygen saturation between 93% and 96%. Exogenous surfactant was given when FIO2 requirement was >0.4 in nCPAP in the presence of radiological signs of respiratory distress syndrome.Main outcome measures: Primary end point: need for exogenous surfactant. Secondary end points: need for mechanical ventilation and incidence of air leaks.Results: Surfactant was needed by 22.6% in the prophylaxis group and 21.7% in the rescue group. Mechanical ventilation was required by 12.2% in both the prophylaxis and rescue group. The incidence of air leaks was 2.6% in both groups. More than 80% of both groups had received prenatal steroids.Conclusions: In newborns of 28-31 weeks gestation, there is no greater benefit in giving prophylactic nCPAP than in starting nCPAP when the oxygen requirement increases to a FIO2 >0.4.