Intervention Review

Supplemental oxygen for the treatment of prethreshold retinopathy of prematurity

  1. Jane Lloyd2,
  2. Lisa M Askie1,*,
  3. Jeremy Smith3,
  4. William O Tarnow-Mordi2

Editorial Group: Cochrane Neonatal Group

Published Online: 22 APR 2003

Assessed as up-to-date: 2 DEC 2002

DOI: 10.1002/14651858.CD003482


How to Cite

Lloyd J, Askie LM, Smith J, Tarnow-Mordi WO. Supplemental oxygen for the treatment of prethreshold retinopathy of prematurity. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD003482. DOI: 10.1002/14651858.CD003482.

Author Information

  1. 1

    University of Sydney, NHMRC Clinical Trials Centre, Camperdown, NSW, Australia

  2. 2

    Westmead Hospital, Department of Neonatal Medicine, Westmead, NSW, Australia

  3. 3

    Westmead Hospital, Ophthalmology, Westmead, Australia

*Lisa M Askie, NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW, 2050, Australia. laskie@ctc.usyd.edu.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 22 APR 2003

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Abstract

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

Background

Oxygen has long been implicated in the pathogenesis of retinopathy of prematurity (ROP) and is rigorously monitored in today's neonatal intensive care units. Recent research using a feline model has shown an improvement in ROP outcome of kittens treated with supplemental oxygen. Current treatment for ROP by retinal ablation is not without complications so a non-invasive method of treatment is preferred. The possible effects of long term oxygen supplementation on chronic lung disease, length of hospital stay and growth and development are, however, unknown.

Objectives

To determine whether, in preterm or low birth weight infants with prethreshold ROP, targeting higher as compared to normal transcutaneous oxygen levels or pulse oximetry levels when using supplemental oxygen reduces the progression of ROP to threshold disease and improves visual outcome without any adverse effects.

Search methods

The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of the Oxford Database of Perinatal Trials, MEDLINE, previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants and journal handsearching. An additional literature search of the MEDLINE (1966 to June 2002), EMBASE (1980 to April 2002), and CINAHL (1982 to April 2002) databases was conducted in order to locate any trials in addition to those provided by the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 2, 2002).

Selection criteria

All randomised or quasi randomised studies comparing higher versus normal target oxygen levels in preterm or low birthweight infants with prethreshold ROP were eligible for inclusion.

Data collection and analysis

The methodological quality of the one eligible trial was assessed independently by two authors for the degree of selection, performance, attrition and detection bias. Data regarding clinical outcomes including progression to threshold ROP, blindness or severe visual impairment, mortality, respiratory morbidities and long term growth were extracted and reviewed independently by two authors. Results were compared and differences resolved as required. Data analysis was conducted according to the standards of the Cochrane Neonatal Review Group.

Main results

The one trial included in this review enrolled 649 infants. There was a trend for supplemental oxygen to reduce the progression to threshold ROP, however this did not reach statistical significance (RR 0.84, 95% CI 0.70, 1.02). A subgroup analysis of those infants without plus disease showed significantly fewer infants progressing to threshold ROP in infants treated with supplemental oxygen. However this analysis was not pre-specified so these results should be interpreted with caution. No significant effects were detected on blindness or severe visual function at three months corrected age, mortality, pneumonia, chronic lung disease or weight gain. Adverse pulmonary events were more common in the higher oxygen saturation group and these infants were in hospital and on supplemental oxygen for longer. Longer term visual outcomes were not reported.

Authors' conclusions

The results of this systematic review do not show a statistically significant reduction in the rate of progression to threshold ROP with supplemental oxygen treatment, but reveal increased adverse pulmonary sequelae with higher oxygen targeting in this group of preterm infants. Future research needs to be directed towards the question of whether infants without plus disease are more likely to respond to supplemental oxygen therapy than those with plus disease.

 

Plain language summary

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

Supplemental oxygen for the treatment of prethreshold retinopathy of prematurity

Increased oxygen supplementation for babies with signs of worsening retinopathy of prematurity (ROP) may not prevent development of this eye disease, and may lead to lung complications. Very preterm babies are at risk of damage to their sight from ROP (retinopathy of prematurity). Oxygen plays a part in the development of ROP. The amount of oxygen babies receive in neonatal intensive care is very carefully monitored to try to lower the risk of ROP and limit the possibility of lung damage. One option is increasing the oxygen level to babies who are showing signs of worsening ROP. However, the review of the one available trial found that increased supplemental oxygen did not reduce the chances of ROP progressing, but may harm the lungs of babies showing signs of worsening ROP.

 

摘要

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

背景

給予氧氣來治療未達閥值的早產視網膜病變

對於早產視網膜病變(ROP)而言,長期以來,人們都認為氧氣是造成它發病的原因,因此現今的新生兒加護病房,都會對氧氣進行嚴格的監控。近期有1個以貓為模型的研究顯示,給予氧氣之後,改善了小貓產生早產視網膜病變之預後。對於早產視網膜病變而言,目前以視網膜燒灼術來進行的治療方式並不能夠避免併發症的出現,所以人們希望能夠有1種不具有侵入性的治療方法。然而,對於慢性肺部疾病、住院的長度,以及成長與發育等層面而言,長期給予氧氣所可能帶來的影響,都還是未知的。

目標

對於早產或是出生時體重過輕、而且又患有未達閥值的早產視網膜病變之嬰兒而言,要確認在給予氧氣以達到更高的經皮氧氣濃度或是脈搏血氧儀的濃度,比較起正常的濃度來說,是否可因此減低早產視網膜病變發展至閥值,然後在沒有不良影響的情況下使視力獲得改善。

搜尋策略

利用Cochrane Neonatal Review Group標準的搜尋策略,包含搜尋Oxford Database of Perinatal Trials、MEDLINE、先前的文獻回顧,包括交叉對照參考資料、摘要、研討會及座談會手冊、專家意見、並且人工搜尋期刊。並且額外利用下述資料庫進行文獻搜尋:MEDLINE (1966年2002年6月) 、EMBASE (1980年2002年4月) 、以及 CINAHL (1982年2002年4月) 以搜集Cochrane Controlled Trials Register (CENTRAL/CCTR, Cochrane Library Issue 2, 2002) 所提供之外的試驗。

選擇標準

針對早產或是出生時體重過輕、而且又患有未達閥值的早產視網膜病變之嬰兒而言,所有隨機化或是半隨機化的研究,將較高與正常的預期氧氣濃度進行了比較,這些研究將符合收集的規定。

資料收集與分析

1份合格試驗在方法學方面的品質,是由2位作者針對選擇的等級、效能、摩擦程度,以及偵測誤差等方面,獨立地進行過評估。惡化至閥值的早產視網膜病變、眼盲或是嚴重的視力障礙、死亡率、呼吸方面的罹病率,以及長期的生長狀況等臨床預後,由2位作者獨立地對這些資料進行了擷取與檢視。這些結果之間會進行比較,並且解決當中的差異。資料分析則是根據the Cochrane Neonatal Review Group的標準來進行。

主要結論

在本篇回顧當中收集的這1份試驗,共包含了649名嬰兒。補充氧氣有減低惡化至閥值的早產視網膜病變之趨勢,然而沒有構成統計學上的差異(RR 0.84,95% CI 0.70,1.02)。在沒有發生正向病症 (plus disease) 的那些次群組之嬰兒們,分析顯示有使用補充氧氣來有意義地比較少會惡化成閥值的早產視網膜病變。然而,這分析並沒有預先指定,所以在解釋這些結果的時候應該要格外謹慎。在矯正年齡達到3個月大時發生眼盲或是嚴重的視力障礙、死亡率、肺炎、慢性肺部疾病,或是體重上升等方面,並沒有偵測到任何顯著的影響。在氧氣飽和濃度較高的那組當中,會更容易發生不良的肺部問題,而且這些嬰兒們會住院較久且需要接受更久的氧氣。長期的視力狀況,則沒有這方面的報告。

作者結論

本篇系統性回顧的結果並沒有顯示使用氧氣治療會有統計學上的有意義地使惡化成閥值的早產視網膜病變之發生降低,但是在這一組使用較高氧氣的早產兒,卻顯示出不良的肺部後遺症情況會變多。將來的研究方向,則必須要朝著,是否在沒有發生正向病症的嬰兒們,比起有正向病症的嬰兒們,會更有可能對補充氧氣的療法產生反應。

翻譯人

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

總結

對於早產視網膜病變(ROP)出現了情況惡化的徵兆時,在這些嬰兒們身上提高氧氣的補充量,可能無法預防這種眼部疾病的發展,而且還有可能會導致肺部的併發症。非常早產的嬰兒們處於 ROP(過早發育而形成的視網膜病變)造成的視力傷害之風險當中。在早產視網膜病變之形成過程中,氧氣扮演了某個部份的角色。對於新生兒的重症照護而言,給予嬰兒們的氧氣量會受到非常仔細的監控,以試著降低早產視網膜病變之風險,並且減少發生肺部傷害的可能性。對於因為早產視網膜病變出現了情況惡化的徵兆時,提高這些嬰兒們身上氧氣的濃度,則是1種可以選擇的方式。然而,本篇回顧中只有1份可取得的試驗,而且內容中發現,在出現了早產視網膜病變惡化的徵兆之嬰兒,增加補充的氧氣量也不能夠減少早產視網膜病變的惡化,但是卻可能會對這些嬰兒們的肺部構成危害。