Very Early Surfactant Without Mandatory Ventilation in Premature Infants Treated With Early Continuous Positive Airway Pressure: A Randomized, Controlled Trial
Very Early Surfactant Without Mandatory Ventilation in Premature Infants Treated With Early Continuous Positive Airway Pressure: A Randomized, Controlled Trial
复制标题
DOI：
10.1542/peds.2007-3501
复制
发表时间：
2009-01-01
期刊：
影响因子：
8
通讯作者：
Lucia Jaramillo, Martha
中科院分区：
文献类型：
--
作者：
Rojas, Mario Augusto;Manuel Lozano, Juan;Lucia Jaramillo, Martha
背景慢性肺部疾病是早产最常见和最严重的并发症之一。由于机械通气是慢性肺部疾病的主要危险因素，因此早期应用经鼻持续气道正压通气已被用作避免早产儿机械通气的策略。表面活性物质治疗可改善早产儿的短期呼吸状态，但其使用传统上仅限于机械通气的婴儿。经鼻持续气道正压通气治疗的婴儿在短暂的插管期内尽早给予表面活性物质可改善其预后，并进一步减少机械通气的需要。我们的目的是确定在出生后不久接受鼻持续气道正压通气治疗的极早产儿中，不使用强制性通气的极早期表面活性剂治疗是否能改善预后，并减少对机械通气的需求。哥伦比亚的八个中心参加了这项随机对照试验。出生于孕27 ~ 31周（6/7）的有呼吸窘迫症状并在产房接受辅助供氧治疗的婴儿，在出生后1小时内随机分为两组：插管组、极早期表面活性剂组、拔管组和经鼻持续气道正压通气组（治疗组）或单纯经鼻持续气道正压通气组（对照组）。主要结果是需要使用预先定义的标准进行后续机械通气。从2004年1月1日至2006年12月31日，279名婴儿被随机分配，141名进入治疗组，138名进入对照组。与对照组（39%）相比，治疗组（26%）的机械通气需求较低。治疗组漏气综合征发生率（2%）低于对照组（9%）。与对照组（26%）相比，治疗组（12%）在出生后第一个小时接受表面活性剂治疗的患者百分比也显著降低。治疗组的慢性肺部疾病发生率（经后36周氧疗）为49%，对照组为59%。所有其他结局，包括死亡率、脑室内出血和脑室周围白质软化在两组之间相似。在出生后早期接受经鼻持续气道正压通气治疗的早产儿中，在没有强制通气的情况下，添加非常早期的表面活性物质治疗减少了随后机械通气的需要，降低了漏气综合征的发生率，并且似乎是安全的。在医疗资源有限的情况下，减少机械通气的需求是一个重要的结果，并可能导致发达国家和发展中国家的慢性肺病减少。儿科2009; 123：137-142
BACKGROUND. Chronic lung disease is one of the most frequent and serious complications of premature birth. Because mechanical ventilation is a major risk factor for chronic lung disease, the early application of nasal continuous positive airway pressure has been used as a strategy for avoiding mechanical ventilation in premature infants. Surfactant therapy improves the short-term respiratory status of premature infants, but its use is traditionally limited to infants being mechanically ventilated. Administration of very early surfactant during a brief period of intubation to infants treated with nasal continuous positive airway pressure may improve their outcome and further decrease the need for mechanical ventilation.OBJECTIVE. Our goal was to determine if very early surfactant therapy without mandatory ventilation improves outcome and decreases the need for mechanical ventilation when used in very premature infants treated with nasal continuous positive airway pressure soon after birth.DESIGN/METHODS. Eight centers in Colombia participated in this randomized, controlled trial. Infants born between 27 and 31(6/7) weeks' gestation with evidence of respiratory distress and treated with supplemental oxygen in the delivery room were randomly assigned within the first hour of life to intubation, very early surfactant, extubation, and nasal continuous positive airway pressure (treatment group) or nasal continuous airway pressure alone (ontrol group). The primary outcome was the need for subsequent mechanical ventilation using predefined criteria.RESULTS. From January 1, 2004, to December 31, 2006, 279 infants were randomly assigned, 141 to the treatment group and 138 to the control group. The need for mechanical ventilation was lower in the treatment group (26%) compared with the control group (39%). Air- leak syndrome occurred less frequently in the treatment group (2%) compared with the control group (9%). The percentage of patients receiving surfactant after the first hour of life was also significantly less in the treatment group (12%) compared with the control group (26%). The incidence of chronic lung disease (oxygen treatment at 36 weeks' postmenstrual age) was 49% in the treatment group compared with 59% in the control group. All other outcomes, including mortality, intraventricular hemorrhage, and periventricular leukomalacia were similar between the groups.CONCLUSIONS. In premature infants treated with nasal continuous positive airway pressure early after birth, the addition of very early surfactant therapy without mandatory ventilation decreased the need for subsequent mechanical ventilation, decreased the incidence of air-leak syndrome, and seemed to be safe. Reduction in the need for mechanical ventilation is an important outcome when medical resources are limited and may result in less chronic lung disease in both developed and developing countries. Pediatrics 2009; 123: 137-142