Intervention Review

Antibiotic regimens for suspected late onset sepsis in newborn infants

  1. Adrienne Gordon1,*,
  2. Heather E Jeffery2

Editorial Group: Cochrane Neonatal Group

Published Online: 20 JUL 2005

Assessed as up-to-date: 1 MAR 2005

DOI: 10.1002/14651858.CD004501.pub2

How to Cite

Gordon A, Jeffery HE. Antibiotic regimens for suspected late onset sepsis in newborn infants. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD004501. DOI: 10.1002/14651858.CD004501.pub2.

Author Information

  1. 1

    RPA Women and Babies, Royal Prince Alfred Hospital, RPA Newborn Care, Sydney, NSW, Australia

  2. 2

    RPA Women and Babies, Royal Prince Alfred Hospital and University of Sydney, School of Public Health, RPA Newborn Care, Sydney, NSW, Australia

*Adrienne Gordon, RPA Newborn Care, RPA Women and Babies, Royal Prince Alfred Hospital, Missenden Road, Camperdown, Sydney, NSW, 2050, Australia.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 20 JUL 2005




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


Late onset neonatal sepsis (systemic infection after 48 hours of age) continues to be a significant cause of morbidity and mortality. Early treatment with antibiotics is essential as infants can deteriorate rapidly. It is not clear which antibiotic regimen is most suitable for initial treatment of suspected late onset sepsis.


To compare the effectiveness and adverse effects of different antibiotic regimens for treatment of suspected late onset sepsis in newborn infants.

Search methods

The standard search strategy of the Cochrane Neonatal Review Group was used. This includes electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2004), MEDLINE (1966 - Dec 2004), EMBASE (1980 - Dec 2004) and CINAHL (1982 - Dec 2004), electronic abstracts of Pediatric Academic Society meetings (1996 - Dec 2004) and previous reviews including cross references (all articles referenced).

Selection criteria

Randomised and quasi randomised controlled trials comparing different initial antibiotic regimens in neonates with suspected late onset sepsis were evaluated.

Data collection and analysis

Both reviewer authors screened abstracts and papers against the inclusion criteria, appraised the quality of and extracted data from papers. For dichotomous outcomes, treatment effect was expressed as relative risk and risk difference with 95% confidence intervals. NNT was calculated for outcomes for which there was a statistically significant reduction in risk difference.

Main results

Thirteen studies were identified as possibly eligible for inclusion. The majority of studies were excluded as they did not separate data for early and late onset infection. Two studies are still awaiting assessment. Only one small study, in 24 neonates, was included in this review. It compared beta-lactam therapy with a combination of beta lactam plus aminoglycoside. The study did not meet our prespecified criteria for good methodological quality. In babies with suspected infection there was no significant difference in mortality (RR 0.17, 95% CI 0.01 to 3.23) or treatment failure (RR 0.17, 95% CI 0.01 to 3.23). Antibiotic resistance was assessed and there were no cases in either group.

Authors' conclusions

There is inadequate evidence from randomised trials in favour of any particular antibiotic regimen for the treatment of suspected late onset neonatal sepsis. The available evidence is not of high quality. Although suspected sepsis and antibiotic use is common, quality research is required to specifically address both narrow and broad spectrum antibiotic use for late onset neonatal sepsis. Future research also needs to assess cost effectiveness and the impact of antibiotics in different settings such as developed or developing countries and lower gestational age groups.


Plain language summary

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

Antibiotic regimens for suspected late onset sepsis in newborn infants

Antibiotics for newborn infants that might have blood infections when more than 48 hours old. Blood infection (sepsis) can make newborn infants seriously ill or even kill them. Sepsis in newborns more than 48 hours old is called late onset neonatal sepsis; it is usually caused by bacteria, and sometimes by fungal infection. Doctors often give antibiotics if they suspect this dangerous condition as it can be difficult to tell if a newborn has late onset neonatal sepsis. Certain antibiotics given for this condition can have serious side effects, including antibiotic resistance, which can result in worse infection. This Cochrane review examined which antibiotics are best for treating late onset neonatal sepsis, in terms of effectiveness and side effects. The authors searched the medical literature and found only one study that met all the criteria the authors were looking for. This study, from 1988, enrolled 28 newborn infants. Some of the newborns received a beta lactam antibiotic by itself while others got the beta lactam plus another antibiotic, an aminoglycoside. There were no significant differences between the two kinds of antibiotic treatment in this study. The Cochrane review authors concluded that there is not enough research to recommend one kind of antibiotic treatment over another for late onset neonatal sepsis.



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



晚發性新生兒敗血症(出生48小時後全身感染)仍然是新生兒一個重要發病率和死亡率的原因。早期使用抗生素治療是必要的,因為嬰兒病情會迅速惡化。目前尚不清楚當疑似晚發性敗血症發生時, 哪種抗生素療法是最適合的初步治療。




使用Cochrane新生兒審查小組的標準搜索策略。這包括電子檢索Cochrane對照試驗中心註冊(CENTRAL, The Cochrane Library,,第4期,2004年),MEDLINE(1966年  2004年12月),EMBASE(1980  2004年12月)和CINAHL(1982年  2004年12月),兒科學術協會會議的電子摘要(1996年  2004年12月)和以往的review,包括交叉引用(所有文章都引用)。






13個研究被確定為可能有資格納入。多數人的研究被排除,因為他們沒有單獨的數據來說明是早期或晚期發病的感染。2項研究仍有待評估。只有1個小型研究(24新生兒),被列入這次review。它比較β lactam治療與βlactam加aminoglycoside。以優良的方法學品質而言, 這項研究並沒有達到我們預先設定的標準。對疑似感染的嬰兒來說, 在死亡率(RR 0.17,95%CI為 0.01至3.23)或 治療失敗(RR 0.17,95%CI為 0.01至3.23)並無顯著差異。抗生素耐藥性有被進行評估,沒有任何一組有抗藥性發生。





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


抗生素應用於懷疑出生後48小時的新生嬰兒有血液感染。血液感染(敗血症)可以使新生嬰兒患重病,甚至致死. 新生兒敗血症在出生48小時以上的稱為晚發性新生兒敗血症,它通常是由細菌引起的,有時是由真菌感染。如果醫生懷疑有這危險的情況時常會給予抗生素,因為新生兒是否發生晚發性新生兒敗血症是很難分辨的。某些抗生素在這種情況下給予會產生嚴重的副作用,包括耐藥性,這可能會導致更壞的感染。這次 Cochrane review研究哪一種抗生素是治療晚發性新生兒敗血症最好的選擇,這包括考量有效性和副作用。作者們搜查了醫學文獻研究,發現只有一個研究能夠滿足想要符合的所有條件。這項研究從 1988年納入了28個新生兒。一些新生兒使用βlactam,而其他的則使用βlactam加另一種抗生素,aminoglycoside。 發現這兩種配方沒有顯著的差異。本 Cochrane review作者的結論是沒有足夠的研究建議治療晚發性新生兒敗血症時, 哪一種抗生素是比較有效的。