Ho Jacqueline J, Subramaniam Prema, Davis Peter G
Department of Paediatrics, RCSI & UCD Malaysia Campus (formerly Penang Medical College), George Town, Malaysia.
Paediatric Department, Mount Isa Base Hospital, Mount Isa, Australia.
Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD002271. doi: 10.1002/14651858.CD002271.pub3.
Respiratory distress, particularly respiratory distress syndrome (RDS), is the single most important cause of morbidity and mortality in preterm infants. In infants with progressive respiratory insufficiency, intermittent positive pressure ventilation (IPPV) with surfactant has been the usual treatment, but it is invasive, potentially resulting in airway and lung injury. Continuous positive airway pressure (CPAP) has been used for the prevention and treatment of respiratory distress, as well as for the prevention of apnoea, and in weaning from IPPV. Its use in the treatment of RDS might reduce the need for IPPV and its sequelae.
To determine the effect of continuous distending pressure in the form of CPAP on the need for IPPV and associated morbidity in spontaneously breathing preterm infants with respiratory distress.
We used the standard strategy of Cochrane Neonatal to search CENTRAL (2020, Issue 6); Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions; and CINAHL on 30 June 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
All randomised or quasi-randomised trials of preterm infants with respiratory distress were eligible. Interventions were CPAP by mask, nasal prong, nasopharyngeal tube or endotracheal tube, compared with spontaneous breathing with supplemental oxygen as necessary.
We used standard methods of Cochrane and its Neonatal Review Group, including independent assessment of risk of bias and extraction of data by two review authors. We used the GRADE approach to assess the certainty of evidence. Subgroup analyses were planned on the basis of birth weight (greater than or less than 1000 g or 1500 g), gestational age (groups divided at about 28 weeks and 32 weeks), timing of application (early versus late in the course of respiratory distress), pressure applied (high versus low) and trial setting (tertiary compared with non-tertiary hospitals; high income compared with low income) MAIN RESULTS: We included five studies involving 322 infants; two studies used face mask CPAP, two studies used nasal CPAP and one study used endotracheal CPAP and continuing negative pressure for a small number of less ill babies. For this update, we included one new trial. CPAP was associated with lower risk of treatment failure (death or use of assisted ventilation) (typical risk ratio (RR) 0.64, 95% confidence interval (CI) 0.50 to 0.82; typical risk difference (RD) -0.19, 95% CI -0.28 to -0.09; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 4 to 11; I = 50%; 5 studies, 322 infants; very low-certainty evidence), lower use of ventilatory assistance (typical RR 0.72, 95% CI 0.54 to 0.96; typical RD -0.13, 95% CI -0.25 to -0.02; NNTB 8, 95% CI 4 to 50; I = 55%; very low-certainty evidence) and lower overall mortality (typical RR 0.53, 95% CI 0.34 to 0.83; typical RD -0.11, 95% CI -0.18 to -0.04; NNTB 9, 95% CI 2 to 13; I = 0%; 5 studies, 322 infants; moderate-certainty evidence). CPAP was associated with increased risk of pneumothorax (typical RR 2.48, 95% CI 1.16 to 5.30; typical RD 0.09, 95% CI 0.02 to 0.16; number needed to treat for an additional harmful outcome (NNTH) 11, 95% CI 7 to 50; I = 0%; 4 studies, 274 infants; low-certainty evidence). There was no evidence of a difference in bronchopulmonary dysplasia, defined as oxygen dependency at 28 days (RR 1.04, 95% CI 0.35 to 3.13; I = 0%; 2 studies, 209 infants; very low-certainty evidence). The trials did not report use of surfactant, intraventricular haemorrhage, retinopathy of prematurity, necrotising enterocolitis and neurodevelopment outcomes in childhood.
AUTHORS' CONCLUSIONS: In preterm infants with respiratory distress, the application of CPAP is associated with reduced respiratory failure, use of mechanical ventilation and mortality and an increased rate of pneumothorax compared to spontaneous breathing with supplemental oxygen as necessary. Three out of five of these trials were conducted in the 1970s. Therefore, the applicability of these results to current practice is unclear. Further studies in resource-poor settings should be considered and research to determine the most appropriate pressure level needs to be considered.
呼吸窘迫,尤其是呼吸窘迫综合征(RDS),是早产儿发病和死亡的最重要单一原因。对于进行性呼吸功能不全的婴儿,使用表面活性剂的间歇性正压通气(IPPV)一直是常规治疗方法,但它具有侵入性,可能导致气道和肺损伤。持续气道正压通气(CPAP)已被用于预防和治疗呼吸窘迫、预防呼吸暂停以及从IPPV撤机。其用于治疗RDS可能会减少对IPPV及其后遗症的需求。
确定以CPAP形式的持续扩张压力对患有呼吸窘迫的自主呼吸早产儿使用IPPV的需求及相关发病率的影响。
我们采用Cochrane新生儿组的标准策略检索CENTRAL(2020年第6期);Ovid MEDLINE及印刷版之前的Epub、在研及其他未索引引文、每日更新版;以及2020年6月30日的CINAHL。我们还检索了临床试验数据库以及检索到的文章的参考文献列表,以查找随机对照试验和半随机试验。
所有关于患有呼吸窘迫的早产儿的随机或半随机试验均符合条件。干预措施为通过面罩、鼻导管、鼻咽管或气管内导管进行CPAP,与必要时补充氧气的自主呼吸进行比较。
我们采用Cochrane及其新生儿综述组的标准方法,包括两名综述作者独立评估偏倚风险和提取数据。我们采用GRADE方法评估证据的确定性。计划根据出生体重(大于或小于1000g或1500g)、胎龄(约28周和32周划分组)、应用时机(呼吸窘迫过程中早期与晚期)、应用压力(高与低)以及试验环境(三级医院与非三级医院;高收入与低收入)进行亚组分析。主要结果:我们纳入了五项研究,涉及3例婴儿;两项研究使用面罩CPAP,两项研究使用鼻CPAP,一项研究使用气管内CPAP并对少数病情较轻的婴儿持续施加负压。对于本次更新,我们纳入了一项新试验。CPAP与较低的治疗失败风险(死亡或使用辅助通气)相关(典型风险比(RR)0.64,95%置信区间(CI)0.50至0.82;典型风险差(RD)-0.19,95%CI -0.28至-0.09;为获得额外有益结果所需治疗的人数(NNTB)6,95%CI 4至11;I² = 50%;5项研究,3例婴儿;极低确定性证据)、较低的通气辅助使用(典型RR 0.72,95%CI 0.54至0.96;典型RD -0.13,95%CI -0.25至-0.02;NNTB 8,95%CI 4至50;I² = 55%;极低确定性证据)以及较低的总体死亡率(典型RR 0.53,95%CI 0.34至0.83;典型RD -0.11,95%CI -0.18至-0.04;NNTB 9,95%CI 2至13;I² = 0%;5项研究,3例婴儿;中等确定性证据)。CPAP与气胸风险增加相关(典型RR 2.48,95%CI 1.16至5.30;典型RD 0.09,95%CI 0.02至0.16;为获得额外有害结果所需治疗的人数(NNTH)11,95%CI 7至50;I² = 0%;4项研究,2例婴儿;低确定性证据)。没有证据表明在28天需氧依赖定义的支气管肺发育不良方面存在差异(RR 1.04,95%CI 0.35至3.13;I² = 0%;2项研究,2例婴儿;极低确定性证据)。这些试验未报告表面活性剂的使用、脑室内出血、早产儿视网膜病变、坏死性小肠结肠炎以及儿童期神经发育结局。
在患有呼吸窘迫的早产儿中,与必要时补充氧气的自主呼吸相比,应用CPAP与呼吸衰竭、机械通气使用和死亡率降低以及气胸发生率增加相关。这些试验中有五分之三是在20世纪70年代进行的。因此,这些结果在当前实践中的适用性尚不清楚。应考虑在资源匮乏环境中进行进一步研究,并考虑开展研究以确定最合适的压力水平。