Intervention Review

Anticonvulsants for preventing mortality and morbidity in full term newborns with perinatal asphyxia

  1. David J Evans1,*,
  2. Malcolm Levene2,
  3. Maria Tsakmakis3

Editorial Group: Cochrane Neonatal Group

Published Online: 18 JUL 2007

Assessed as up-to-date: 7 MAR 2007

DOI: 10.1002/14651858.CD001240.pub2


How to Cite

Evans DJ, Levene M, Tsakmakis M. Anticonvulsants for preventing mortality and morbidity in full term newborns with perinatal asphyxia. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD001240. DOI: 10.1002/14651858.CD001240.pub2.

Author Information

  1. 1

    Southmead Hospital, Neonatal Intensive Care Unit, Bristol, UK

  2. 2

    General Infirmary at Leeds, Department of Pediatrics, Leeds, UK

  3. 3

    North Bristol NHS Trust, Department of Neonatal Medicine, Bristol, UK

*David J Evans, Neonatal Intensive Care Unit, Southmead Hospital, Bristol, BS10 5NB, UK. david.evans@nbt.nhs.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 JUL 2007

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Abstract

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

Background

Seizures are common following perinatal asphyxia and may exacerbate secondary neuronal injury by increasing cerebral metabolic demand, causing fluctuations in oxygenation and perfusion, and triggering the release of excitatory neurotransmitters. Anticonvulsant therapy has been used in infants with perinatal asphyxia in order to prevent seizures. However, long term anticonvulsant therapy may lead to inhibition of brain development. Therefore, the routine use of anticonvulsant therapy to prevent seizures following perinatal asphyxia needs to be evaluated.

Objectives

To assess the effect of administering anticonvulsants to infants of 37 weeks gestation or more following perinatal asphyxia on death or subsequent severe neurodevelopmental disability and/or the prevention of seizures.

Search methods

Relevant randomised controlled trials were identified using a combination of electronic database searches, hand searches and a search of the Cochrane Controlled Trials Registry.

Selection criteria

All randomised or quasi-randomised controlled clinical trials that reported data comparing the following outcomes: mortality, neurodevelopmental disability, neonatal seizures and adverse events, following anticonvulsant therapy in term infants (37 weeks or more) compared to controls (with or without placebo) following perinatal asphyxia.

Data collection and analysis

Methodological quality and validity of studies were assessed without consideration of the results. Data relevant to the outcome were extracted and analysed.

Main results

Seven randomised or quasi-randomised controlled trials that met the selection criteria were included. No studies were of sufficient methodological quality and size to demonstrate a valid, clinically significant change in the risk of mortality or severe neurodevelopmental disability. A meta-analysis combining five studies comparing barbiturates with conventional therapy following perinatal asphyxia demonstrated no difference in risks of death, severe neurodevelopmental disability, or the combined outcome of death or severe neurodevelopmental disability.

Authors' conclusions

At the present time, anticonvulsant therapy to term infants in the immediate period following perinatal asphyxia cannot be recommended for routine clinical practice, other than in the treatment of prolonged or frequent clinical seizures. Any future studies should be of sufficient size to have the power to detect clinically important reductions in mortality and severe neurodevelopmental disability.

 

Plain language summary

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

Anticonvulsants for preventing mortality and morbidity in full term newborns with perinatal asphyxia

It is unclear whether giving anticonvulsants to newborn babies soon after possible birth asphyxia at term is safe and effective. More studies are needed. Seizures (or convulsions) are common following birth asphyxia. These seizures may worsen the brain injury. In theory, anticonvulsant medication given to babies soon after possible birth asphyxia may improve outcome by preventing seizures and protecting the brain. Anticonvulsant drugs are not without side effects and there are concerns that they might impair brain development. The studies included in this review involved relatively small numbers of babies and few studies assessed developmental outcome. At present, there is insufficient information on which to base recommendations about the effectiveness of giving anticonvulsants to newborn babies soon after possible birth asphyxia.

 

摘要

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

背景

抗痙攣藥物預防足月新生兒周產期窒息死亡率和發病率

周產期窒息後常出現痙攣,並且可能因為造成腦部代謝需求上升、造成血氧及灌注波動、並且觸動釋放興奮性神經傳導物,因而造成第二神經元受損。抗痙攣療法已用於周產期窒息的嬰兒,以防止發作。然而,長期痙攣藥物治療可能會導致大腦發育的抑制作用。因此,有必要評估周產期窒息後利用抗痙攣藥物預防發作的效果。

目標

評估在新生兒(妊娠37週以上)窒息後,施用抗痙攣藥物,對於死亡或嚴重的神經後殘疾和/或預防痙攣發作的影響。

搜尋策略

同時利用電子資料庫、人工搜尋以及搜尋Cochrane Controlled Trials Registry以找出相關的隨機對照試驗。

選擇標準

所有隨機或半隨機對照臨床試驗,針對在周產期窒息後,使用抗痙攣藥物治療足月兒(37週或以上),與對照組相比(有或沒有安慰劑),比較以下結果指標:死亡率、神經發育殘疾、新生兒痙攣和不良事件。

資料收集與分析

評估研究的方法學品質和有效性,而不考慮結果。提取相關的數據結果進行分析。

主要結論

7個隨機或半隨機對照試驗符合納入標準。沒有一個研究的品質與樣本數足以證實對於死亡或是嚴重的神經發展的風險有效或是具有臨床上的顯著的改變。一個統合分析合併了5個研究,它證實周產期窒息後,利用barbiturates與常規療法,對於死亡風險、嚴重神經發展失能風險、或是合併死亡與嚴重神經發展失能的結果並沒有差異。

作者結論

現階段抗痙攣藥物除了在治療臨床長期或經常發作外,並不建議於作為周產期嬰兒窒息後的常規使用。未來任何的研究都應該要有足夠的樣本數與檢力,以檢驗死亡率與嚴重神經失能等臨床上重要結果。

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

目前還不清楚對於出生不久的新生兒,在窒息後給予抗痙攣藥物是否安全有效。尚需更多的研究。生產窒息後常會出現痙攣(或是抽筋),並造成腦部損傷。 理論上,發生生產窒息後立即給予嬰兒抗痙攣藥物可以預防痙攣及腦部受損,並藉此改善相關結果。不過抗痙攣藥物並非沒有副作用,並且可能會妨礙腦部發育。所納入的研究相對來說嬰兒樣本數較小,並且僅有少數研究評估之後的發育情形。目前對於(可能的)新生兒窒息後立即給予抗痙攣藥物的資訊,並不足夠提供關於療效的建議。