Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants

 

Abstract

Background

Neonatal extracorporeal membrane oxygenation (ECMO) is a complex procedure of life support used in severe but potentially reversible respiratory failure in term infants. Although the number of babies eligible for ECMO is small and the use of ECMO invasive and potentially expensive, its benefits may be high.

Objectives

To determine whether ECMO used for neonatal infants with severe respiratory failure is clinically and cost effective compared to conventional ventilatory support.

Search methods

The Cochrane Neonatal Group Specialised Register, the Cochrane Controlled Trials Register, and MEDLINE were searched for 1974 to 2007.

Selection criteria

All randomised trials comparing neonatal ECMO to conventional ventilatory support.

Data collection and analysis

The authors independently evaluated the trials for methodological quality and appropriateness for inclusion in the Review (without consideration of their results) and independently extracted the data.

Main results

The four trials (three USA and one UK) recruited clinically similar groups of babies. Two trials excluded infants with congenital diaphragmatic hernias. In two trials, transfer for ECMO implied transport over long distances. Two trials had follow-up information. One study included economic evaluation.

The three USA trials had very small numbers of patients. Two trials used conventional randomisation with low potential for bias. Two used less usual designs, which led to difficulties in their interpretation.

All four trials showed strong benefit of ECMO on mortality (typical RR 0.44; 95% CI 0.31 to 0.61), especially for babies without congenital diaphragmatic hernia (typical RR 0.33, 95% CI 0.21 to 0.53).

The UK trial provided follow up information about death or severe disability, and cost-effectiveness, and showed benefit of ECMO at one year (RR 0.56, 95% CI 0.40 to 0.78), four years (RR 0.62, 95% CI 0.45 to 0.86), and seven years (RR 0.64, 95% CI 0.47 to 0.86). Overall nearly half of the children recruited had died or were severely disabled by seven years of age, reflecting the severity of their underlying conditions. A policy of ECMO is as cost-effective as other intensive care technologies in common use.

Authors' conclusions

A policy of using ECMO in mature infants with severe but potentially reversible respiratory failure results in significantly improved survival without increased risk of severe disability. The benefit of ECMO for babies with diaphragmatic hernia is unclear.

Further studies are needed to consider the optimal timing for introducing ECMO; to identify which infants are most likely to benefit; and to address the implications of neonatal ECMO during later childhood and adult life.

 

Plain language summary

Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants

A complex life support procedure, called extracorporeal membrane oxygenation (ECMO), can be used in infants who are near term age to overcome severe, potentially reversible breathing problems. ECMO is similar to the technology used in cardiac bypass surgery. Blood is removed from the body of the patient, oxygen is added to the blood, and the blood is returned to the patient. Although the number of babies requiring ECMO is small, and ECMO is a very invasive and potentially expensive procedure, the benefits of this procedure are high. In this review, four randomized trials that compared the use of ECMO to the conventional approach to supporting these infants with severe breathing problems were identified. Overall, these trials showed a strong benefit for ECMO regarding survival at the time of hospital discharge. This is particularly true for infants without a specific problem of lung formation (congenital diaphragmatic hernia). The result implies that for every three babies with breathing problems and lung failure who were treated with ECMO rather than conventional ventilation, one more infant will survive. Although little information is available regarding long-term follow-up, one trial in the United Kingdom shows both benefits of ECMO and cost-effectiveness of the use of ECMO.

 

摘要

背景

葉克膜體外循環維生系統(Extracorporeal membrane oxygenation)治療新生兒嚴重呼吸衰竭

葉克膜體外循環維生系統(ECMO)是一種複雜的維生系統，用於患有嚴重但可能恢復的呼吸衰竭的成熟新生兒。儘管需要ECMO的嬰兒數很少，而且ECMO具侵入性且昂貴，但其好處也高。

目標

確認與傳統通氣支持方案相比，使用ECMO對嚴重呼吸衰竭新生兒是否具有臨床效益與成本效益。

搜尋策略

搜尋Cochrane Neonatal Group Specialised Register、Cochrane Controlled Trials Register、及MEDLINE，時間自1974年至2007年。

選擇標準

所有對新生兒ECMO與傳統呼吸支持進行比較的隨機試驗。

資料收集與分析

作者們獨立對試驗的研究方法品質及是否符合評價納入標準(不考慮試驗的結果)進行評估，然後獨立提取數據

主要結論

共4個試驗(3個美國，1個英國) 納入臨床上情況相似的嬰兒族群。2個試驗排除先天性橫膈膜疝氣的嬰兒。在2個試驗中，ECMO有轉送，意味著可能長距離輸送。2個試驗有後續追蹤的資料，1個有經濟評估。美國的3個試驗病患數很少。2個試驗採用傳統的隨機分配方式，其可能的偏誤較小。2個採用較不常用的設計，造成外推應用上的困難。所有的研究皆顯示ECMO對於死亡率的效益(RR 0.44; 95% CI 0.31至 0.61)，特別是對於沒有橫膈疝氣的嬰兒(RR 0.33, 95% CI 0.21至0.53)。英國的試驗提供了關於死亡、嚴重失能的後續追蹤資料，並且顯示ECMO在第1年(RR 0.56, 95% CI 0.40 至0.78)、第4年(RR 0.62, 95% CI 0.45至0.86)與第7年(RR 0.64, 95% CI 0.47至0.86)具有效益。整體招募的兒童有一半在七歲時已經死亡或是嚴重失能，顯示他們處境甚艱。使用ECMO與其它常用的重症照護技術一樣具有成本效益。 整體招募的兒童有一半在七歲時已經死亡或是嚴重失能，顯示他們處境甚艱。使用ECMO與其它常用的重症照護技術一樣具有成本效益。

作者結論

在患有可恢復性嚴重呼吸衰竭的成熟嬰兒身上使用ECMO，可以在不增加嚴重風險的情況下，顯著改善其存活率，不過對於患有橫膈膜疝氣嬰兒來說效益仍不明。之後的研究應該考慮到EMCO最佳使用時機，找出對於哪種嬰兒最有效益，並且著重於新生兒使用ECMO對於童年晚期與成年後生活的影響。

翻譯人

本摘要由臺中榮民總醫院葉惠英翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

葉克膜體外循環維生系統(ECMO)的複雜維生系統可以用於成熟新生兒身上，治療嚴重但可能恢復的呼吸問題。 ECMO使用的技巧與心臟繞道手術相似，它將血液自人體抽出，添加入氧氣並且再讓血液會到體內。 儘管需要ECMO的嬰兒數量少，而ECMO又很昂貴，不過效益卻很高。 在本回顧當中，找到了4個隨機試驗比較以ECMO與一般方式用來支持具有呼吸問題嬰兒。整體來說，這些試驗顯示ECMO對於出院存活率有幫助，特別是在沒有其他特定的肺部疾病(先天性橫膈膜疝氣)的嬰兒身上。這些結果顯示，與一般治療相比，每3個使用ECMO的呼吸問題嬰兒就有一個因此受益。雖然後續追蹤的資料很少，1個英國的研究顯示ECMO對於兩者都有效益，並且具有成本效益。