Department of Neonatology, Fernandez Hospital, Hyderabad, Telangana, India.
Vijay Marie Hospital, Hyderabad, Telangana, India.
JAMA Pediatr. 2018 Feb 1;172(2):161-165. doi: 10.1001/jamapediatrics.2017.3873.
Nasal continuous positive airway pressure (NCPAP) as a primary respiratory therapy in meconium aspiration syndrome (MAS) has not been studied extensively. Nasal continuous positive airway pressure, when applied in newborns with MAS, may resolve atelectasis by sufficiently expanding partially obstructed small airways and stabilizing the collapsing terminal airways to enhance oxygen exchange.
To compare NCPAP vs standard care in neonates with moderate to severe respiratory failure due to MAS in reducing the need for invasive ventilation.
DESIGN, SETTINGS, AND PARTICIPANTS: This multicenter open-label, parallel-group (1:1 ratio) randomized clinical trial was conducted from August 5, 2014, to May 26, 2016. Data were collected from 3 tertiary care neonatal intensive care units. All infants admitted with respiratory distress, defined as Downe score greater than 4 and peripheral capillary oxygen saturation less than 90%, were assessed for study eligibility if the chest radiograph was suggestive of MAS and they met the other inclusion criteria: gestation longer than 35 weeks, a birth weight greater than 2000 g, and born through meconium-stained amniotic fluid.
Infants were randomly assigned to either NCPAP or standard care (5-10 L/min hood oxygen).
The primary outcome was the need for mechanical ventilation in the first 7 days of life.
After excluding 14 infants, 67 infants were randomized to bubble NCPAP and 68 infants to standard care. Baseline characteristics were similar between the 2 groups. Infants randomized to the bubble NCPAP group needed mechanical ventilation less frequently in the first 7 days of life compared with standard care (2 [3.0%] vs 17 [25.0%]); odds ratio, 0.09; 95% CI, 0.02-0.43; P = .002). The need for surfactant (3 [4.5%] vs 11 [16.2%]; odds ratio, 0.24; 95% CI, 0.05-0.87) and culture-positive sepsis (4 [6.0%] vs 13 [19.0%]; odds ratio, 0.28; 95% CI, 0.09-0.93) were higher in the standard care group. There was an increased duration of oxygen therapy (median [interquartile range], 45.5 [28.0-78.3] vs 26 [20.0-48.0] hours; P = .001) in the standard care group. In the NCPAP group vs standard care group, incidence of persistent pulmonary hypertension (9 [13%] vs 19 [28%]; odds ratio, 0.42; 95% CI, 0.17-1.01) and duration of hospital stay (median [interquartile range], 5.0 [4.0-8.8] vs 4.0 [4.0-6.0] days; P = .14) were similar.
Bubble NCPAP in comparison with standard care for infants with MAS reduces the need for mechanical ventilation in the first 7 days of life.
Clinical Trial Registry, India Identifier: CTRI/2015/03/005631.
鼻持续气道正压通气（NCPAP）作为胎粪吸入综合征（MAS）的主要呼吸治疗方法尚未得到广泛研究。在患有 MAS 的新生儿中应用 NCPAP 可能通过充分扩张部分阻塞的小气道并稳定塌陷的终末气道来解决肺不张，从而增强氧交换。
比较 NCPAP 与 MAS 导致的中重度呼吸衰竭新生儿的标准护理，以减少有创通气的需求。
设计、地点和参与者：这是一项多中心、开放标签、平行组（1:1 比例）随机临床试验，于 2014 年 8 月 5 日至 2016 年 5 月 26 日进行。数据来自 3 个三级新生儿重症监护病房。所有因呼吸窘迫入院的婴儿，定义为 Downe 评分大于 4 分和外周毛细血管血氧饱和度小于 90%，如果胸片提示 MAS 且符合其他纳入标准，则评估研究的纳入标准：胎龄大于 35 周，出生体重大于 2000 g，胎粪污染羊水分娩。
婴儿随机分配接受 NCPAP 或标准护理（5-10 L/min 罩吸氧）。
主要结局是出生后 7 天内机械通气的需求。
排除 14 名婴儿后，67 名婴儿被随机分配至气泡 NCPAP 组，68 名婴儿被随机分配至标准护理组。两组的基线特征相似。与标准护理组相比，气泡 NCPAP 组在出生后 7 天内需要机械通气的频率较低（2[3.0%]比 17[25.0%]）；比值比，0.09；95%CI，0.02-0.43；P=0.002）。标准护理组需要表面活性剂（3[4.5%]比 11[16.2%]）和培养阳性败血症（4[6.0%]比 13[19.0%]）的可能性更高；比值比，0.24；95%CI，0.05-0.87）。与标准护理组相比，标准护理组的氧疗时间更长（中位数[四分位数范围]，45.5[28.0-78.3]比 26[20.0-48.0]小时；P=0.001）。与标准护理组相比，NCPAP 组持续性肺动脉高压（9[13%]比 19[28%]）和住院时间（中位数[四分位数范围]，5.0[4.0-8.8]比 4.0[4.0-6.0]天）的发生率相似；比值比，0.42；95%CI，0.17-1.01）。
与 MAS 婴儿的标准护理相比，气泡 NCPAP 可减少出生后 7 天内机械通气的需求。
印度临床试验注册中心，标识符：CTRI/2015/03/005631。
