Morley Colin J, Davis Peter G, Doyle Lex W, Brion Luc P, Hascoet Jean-Michel, Carlin John B
Neonatal Services, Royal Women's Hospital, Melbourne, Australia.
N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.
Bronchopulmonary dysplasia is associated with ventilation and oxygen treatment. This randomized trial investigated whether nasal continuous positive airway pressure (CPAP), rather than intubation and ventilation, shortly after birth would reduce the rate of death or bronchopulmonary dysplasia in very preterm infants.
We randomly assigned 610 infants who were born at 25-to-28-weeks' gestation to CPAP or intubation and ventilation at 5 minutes after birth. We assessed outcomes at 28 days of age, at 36 weeks' gestational age, and before discharge.
At 36 weeks' gestational age, 33.9% of 307 infants who were assigned to receive CPAP had died or had bronchopulmonary dysplasia, as compared with 38.9% of 303 infants who were assigned to receive intubation (odds ratio favoring CPAP, 0.80; 95% confidence interval [CI], 0.58 to 1.12; P=0.19). At 28 days, there was a lower risk of death or need for oxygen therapy in the CPAP group than in the intubation group (odds ratio, 0.63; 95% CI, 0.46 to 0.88; P=0.006). There was little difference in overall mortality. In the CPAP group, 46% of infants were intubated during the first 5 days, and the use of surfactant was halved. The incidence of pneumothorax was 9% in the CPAP group, as compared with 3% in the intubation group (P<0.001). There were no other serious adverse events. The CPAP group had fewer days of ventilation.
In infants born at 25-to-28-weeks' gestation, early nasal CPAP did not significantly reduce the rate of death or bronchopulmonary dysplasia, as compared with intubation. Even though the CPAP group had more incidences of pneumothorax, fewer infants received oxygen at 28 days, and they had fewer days of ventilation. (Australian New Zealand Clinical Trials Registry number, 12606000258550.).
支气管肺发育不良与通气和氧疗有关。这项随机试验调查了出生后不久采用经鼻持续气道正压通气(CPAP)而非插管和通气,是否会降低极早产儿的死亡或支气管肺发育不良发生率。
我们将610名孕25至28周出生的婴儿在出生后5分钟随机分配至CPAP组或插管通气组。我们在28日龄、孕36周时及出院前评估结局。
在孕36周时,分配接受CPAP的307名婴儿中,33.9%死亡或患有支气管肺发育不良,而分配接受插管的303名婴儿中这一比例为38.9%(支持CPAP的优势比为0.80;95%置信区间[CI]为0.58至1.12;P = 0.19)。在28日龄时,CPAP组死亡或需要氧疗的风险低于插管组(优势比为0.63;95%CI为0.46至0.88;P = 0.006)。总体死亡率差异不大。在CPAP组,46%的婴儿在出生后前5天内接受了插管,表面活性剂的使用减少了一半。CPAP组气胸发生率为9%,而插管组为3%(P<0.001)。没有其他严重不良事件。CPAP组通气天数更少。
在孕25至28周出生的婴儿中,与插管相比,早期经鼻CPAP并未显著降低死亡或支气管肺发育不良发生率。尽管CPAP组气胸发生率更高,但在28日龄时接受氧疗的婴儿更少,且通气天数更少。(澳大利亚和新西兰临床试验注册号,12606000258550。)