随机试验新生儿复苏中喉罩气道的应用。

A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation.

机构信息

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

出版信息

N Engl J Med. 2020 Nov 26;383(22):2138-2147. doi: 10.1056/NEJMoa2005333.

DOI:10.1056/NEJMoa2005333

PMID:33252870

Abstract

BACKGROUND

Face-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown.

METHODS

In this phase 3, open-label, superiority trial in Uganda, we randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization.

RESULTS

Complete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face-mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P = 0.26). Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), and admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups.

CONCLUSIONS

In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.).

摘要

背景

面罩通气是治疗窒息新生儿最常用的复苏方法。在低收入国家，与面罩通气相比，无囊套喉罩气道（LMA）在新生儿复苏中的潜在优势，但是使用 LMA 是否可以降低窒息新生儿的死亡率和发病率尚不清楚。

方法

在乌干达进行的这项 3 期、开放性标签、优效性试验中，我们将需要正压通气的新生儿随机分配给产婆使用 LMA 或面罩通气。所有新生儿的估计胎龄至少为 34 周，估计出生体重至少为 2000 克，或两者兼有。主要结局是在住院期间 1 至 5 天内发生 7 天内死亡或入住新生儿重症监护病房（NICU）并伴有中重度缺氧缺血性脑病的复合结局。

结果

99.2%的新生儿可获得完整的随访数据。在 LMA 组的 563 名新生儿中，有 154 名（27.4%）发生了主要结局事件，在面罩组的 591 名新生儿中，有 144 名（24.4%）发生了主要结局事件（调整后的相对风险为 1.16；95%置信区间[CI]为 0.90 至 1.51；P=0.26）。在 LMA 组中，有 21.7%的新生儿在 7 天内死亡，而在面罩组中，有 18.4%的新生儿在 7 天内死亡（调整后的相对风险为 1.21；95%CI 为 0.90 至 1.63），在住院期间第 1 至 5 天入住 NICU 并伴有中重度缺氧缺血性脑病的比例分别为 11.2%和 10.1%（调整后的相对风险为 1.27；95%CI 为 0.84 至 1.93）。在缺失数据的新生儿被算作 LMA 组发生主要结局事件且面罩组未发生此类事件的敏感性分析中，结果基本保持不变。两组之间预定的与干预相关的不良事件的发生频率相似。