Intervention Review

Naloxone for preventing morbidity and mortality in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia

  1. William McGuire1,*,
  2. Peter W Fowlie2,
  3. David J Evans3

Editorial Group: Cochrane Neonatal Group

Published Online: 26 JAN 2004

Assessed as up-to-date: 19 MAR 2007

DOI: 10.1002/14651858.CD003955.pub2


How to Cite

McGuire W, Fowlie PW, Evans DJ. Naloxone for preventing morbidity and mortality in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD003955. DOI: 10.1002/14651858.CD003955.pub2.

Author Information

  1. 1

    Australian National University Medical School, Department of Paediatrics and Child Health, Canberra, ACT 2606, Australia

  2. 2

    Ninewells Hospital and Medical School, Women & Child Health, Dundee, Scotland, UK

  3. 3

    Southmead Hospital, Neonatal Intensive Care Unit, Bristol, UK

*William McGuire, Department of Paediatrics and Child Health, Australian National University Medical School, Canberra Hospital Campus, Canberra, ACT 2606, Australia. william.mcguire@act.gov.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 26 JAN 2004

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Studies in animal models have suggested that naloxone, a specific opiate antagonist, may improve outcomes for newborn infants with perinatal asphyxia.

Objectives

To assess the effects of naloxone versus placebo or no drug, and of single versus multiple doses of naloxone, on mortality, long term neurological problems, severity of hypoxic-ischaemic encephalopathy, and frequency of neonatal seizures in newborn infants greater than 34 weeks gestation with suspected perinatal asphyxia.

Search methods

The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2007), MEDLINE (1966 - February 2007), EMBASE (1980 - February 2007), conference proceedings, and previous reviews.

Selection criteria

Randomised or quasi-randomised controlled trials comparing naloxone versus placebo, or no drug, or another dose of naloxone, in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia.

Data collection and analysis

Data was extracted using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two authors. The pre-specified outcomes for this review were: death before hospital discharge, severe neurodevelopmental disability, severity of hypoxic-ischaemic encephalopathy, and seizures in the neonatal period.

Main results

Only one eligible randomised controlled trial was identified. This study compared the use of naloxone with placebo in newborn infants with an Apgar score of six or less at one minute after birth. There were not any data on the pre-specified outcomes for this review.

Authors' conclusions

There are insufficient data available to evaluate the safety and effectiveness of the routine use of naloxone for newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia. A further randomised controlled trial is needed to determine if naloxone benefits newborn infants with suspected perinatal asphyxia. Such a trial should assess clinically important outcomes such as mortality, and adverse short and long term neurological outcomes.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Naloxone for preventing morbidity and mortality in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia

Newborn infants who have been deprived of oxygen before, during, or after delivery ("perinatal asphyxia") are at high risk of dying or developing brain damage. Studies in animal models suggest that over-production of the bodies' own opioids (substances similar to drugs like morphine) is detrimental. Furthermore, researchers have found that giving newborn animals with perinatal asphyxia a drug to counteract the effects of opioids (naloxone, an opioid antagonist) is beneficial. We found only one small randomised controlled trial that examined whether giving naloxone to newborn infants with suspected perinatal asphyxia improved their outcomes, but this trial did not assess the effect on death or disability. Further trials large enough to determine whether naloxone improves survival and/or reduces disability rates are therefore needed.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

Naloxone用於預防34週以上疑似周產期窒息的新生兒發生合併症及死亡

在動物研究暗示naloxone (一種特別的鴉片類阻斷劑) 可改善有周產期窒息新生兒的預後

目標

評估naloxone相較於安慰劑或是沒有用藥物,以及單一相較於多劑量對於死亡率、缺氧缺血性腦病變的嚴重度和發生新生兒痙孿的頻率的效果,研究對象為妊娠週數34週以上懷疑有周產期窒息的新生兒。

搜尋策略

使用Cochrane Neonatal Review Group標準搜尋策略,包括搜尋Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2007) 、 MEDLINE (1966年到2007年2月) 、 EMBASE (1980年到2007年2月) 、研討會紀錄和先前回顧文章。

選擇標準

隨機或半隨機對照試驗比較naloxone與安慰劑、或是沒有用藥物、或是不同劑量的naloxone用於出生34週以上懷疑有周產期窒息的新生兒。

資料收集與分析

使用Cochrane Neonatal Review Group的標準方法來收集資料,兩位作者分別評估試驗品質及資料選取,在這篇回顧文章預先指定的預後有:出院前死亡、嚴重神經發展失能、缺氧缺血性腦病變的嚴重程度以及新生兒時期痙孿。

主要結論

只有一個符合的隨機對照試驗被找出,這個研究比較使用naloxone和安慰劑,使用在出生後一分鐘的Apgar score小於或等於六分的新生兒,在此研究中沒有任何這篇回顧文章預先指定預後的資料。

作者結論

對於出生34週以上懷疑周產期窒息的嬰兒,沒有足夠的資料可用來評估常規使用naloxone的安全性及有效性。需要進一步的隨機對照試驗來決定naloxone是否對懷疑周產期窒息的嬰兒有好處,這個試驗必須評估臨床的重要預後例如死亡和短期及長期神經學不良的預後。

翻譯人

本摘要由馬偕醫院王臻誼翻譯。

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

總結

新生兒在出生前、中、後有發生缺氧 (周產期窒息) ,會增加死亡或是發生腦部傷害的危險性,動物模式的研究發現過度製造自己體內的鴉片類物質 (與嗎啡相似的物質) 是有害的,此外,研究也發現給有周產期窒息剛出生的動物拮抗鴉片類作用的藥物 (naloxone為一種鴉片類拮抗劑) 是有益的。我們只有發現一個小的隨機對照試驗去檢視是否給懷疑有周產期窒息的新生兒naloxone可改善他們的預後,但這個試驗沒有評估對於死亡或是失能的效果,因此需要進一步大型的試驗來決定naloxone是否可以改善存活率和減少失能的比率。