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在新生儿肩部娩出前对胎粪污染的新生儿进行口咽和鼻咽吸引:多中心随机对照试验。

Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial.

作者信息

Vain Nestor E, Szyld Edgardo G, Prudent Luis M, Wiswell Thomas E, Aguilar Adriana M, Vivas Norma I

机构信息

Sanatorio de la Trinidad Hospitals, Buenos Aires, Argentina.

出版信息

Lancet. 2004;364(9434):597-602. doi: 10.1016/S0140-6736(04)16852-9.

DOI:10.1016/S0140-6736(04)16852-9
PMID:15313360
Abstract

BACKGROUND

Meconium aspiration syndrome (MAS) is a life-threatening respiratory disorder in infants born through meconium-stained amniotic fluid (MSAF). Although anecdotal data concerning the efficacy of intrapartum oropharyngeal and nasopharyngeal suctioning of MSAF are conflicting, the procedure is widely used. We aimed to assess the effectiveness of intrapartum suctioning for the prevention of MAS.

METHODS

We designed a randomised controlled trial in 11 hospitals in Argentina and one in the USA. 2514 patients with MSAF of any consistency, gestational age at least 37 weeks, and cephalic presentation were randomly assigned to suctioning of the oropharynx and nasopharynx (including the hypopharynx) before delivery of the shoulders (n=1263), or no suctioning before delivery (n=1251). Postnatal delivery-room management followed Neonatal Resuscitation Program guidelines. The primary outcome was incidence of MAS. Clinicians diagnosing the syndrome and designating other study outcomes were masked to group assignment. An informed consent waiver was used. Analysis was by intention to treat.

FINDINGS

18 infants in the suction group and 15 in the no suction group did not meet entry criteria after random assignment. 87 in the suction group were not suctioned, and 26 in the no suction group were suctioned. No significant difference between treatment groups was seen in the incidence of MAS (52 [4%] suction vs 47 [4%] no suction; relative risk 0.9, 95% CI 0.6-1.3), need for mechanical ventilation for MAS (24 [2%] vs 18 [1%]; 0.8, 0.4-1.4), mortality (9 [1%] vs 4 [0.3%]; 0.4, 0.1-1.5), or in the duration of ventilation, oxygen treatment, and hospital care.

INTERPRETATION

Routine intrapartum oropharyngeal and nasopharyngeal suctioning of term-gestation infants born through MSAF does not prevent MAS. Consideration should be given to revision of present recommendations.

摘要

背景

胎粪吸入综合征(MAS)是一种危及生命的呼吸系统疾病,发生于通过胎粪污染羊水(MSAF)出生的婴儿。尽管关于产时对MSAF进行口咽和鼻咽吸引疗效的轶事性数据相互矛盾,但该操作仍被广泛使用。我们旨在评估产时吸引对预防MAS的有效性。

方法

我们在阿根廷的11家医院和美国的1家医院设计了一项随机对照试验。2514例MSAF质地各异、孕周至少37周且为头先露的患者被随机分配至在胎肩娩出前对口咽和鼻咽(包括下咽)进行吸引组(n = 1263),或胎肩娩出前不进行吸引组(n = 1251)。产后产房管理遵循新生儿复苏项目指南。主要结局是MAS的发生率。诊断该综合征及指定其他研究结局的临床医生对分组情况不知情。使用了知情同意豁免。分析采用意向性分析。

结果

吸引组18例婴儿和非吸引组15例婴儿在随机分组后不符合纳入标准。吸引组87例未进行吸引,非吸引组26例进行了吸引。治疗组之间在MAS发生率(52例[4%]吸引组 vs 47例[4%]非吸引组;相对危险度0.9,95%可信区间0.6 - 1.3)、因MAS需要机械通气(24例[2%] vs 18例[1%];0.8,0.4 - 1.4)、死亡率(9例[1%] vs 4例[0.3%];0.4,0.1 - 1.5)或通气持续时间、氧疗及住院时间方面均未见显著差异。

解读

对通过MSAF出生的足月婴儿进行常规产时口咽和鼻咽吸引并不能预防MAS。应考虑修订当前的推荐意见。

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