Early School-Age Outcomes after exposure to repeat prenatal corticosteroids - a randomised controlled trial

重复使用产前皮质类固醇后的早期学龄结局 - 一项随机对照试验

• 批准号: nhmrc : 453633
• 负责人: A/Pr Ross Haslam
• 金额: $ 72.28万
• 依托单位: The University of Adelaide
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2007
• 资助国家: 澳大利亚
• 起止时间: 2007-01-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/early-school-age-controlled-trial/82093
• 关键词: Early; Age; Outcomes; after; exposure

AIMS OF THE RESEARCH We have recently concluded a large clinical trial in Australia and New Zealand of repeat dose of antenatal corticosteroids given to women who were likely to deliver their baby too early (before 34 weeks of pregnancy). We have been able to show that repeat doses of corticosteroids before birth significantly reduces the risk of the baby developing respiratory difficulties after birth from 41.4% to 32.8%. However, we are not sure if this potentially important improvement will translate into better outcomes for the children as they grow older and reach school-age. As there are many examples of treatments given around the time of birth that have been shown to have some short-term benefits, but substantial long-term harms, we must be as certain as we can be that any advance in one small area of health is not counterbalanced by disadvantages in other health areas. This is particularly important to find out for repeat antenatal corticosteroids given the earlier conflicting reports from non-randomised studies. We plan to assess the 1085 survivors from our earlier clinical trial of repeat dose of prenatal corticosteroids when they are of early school age. We will assess their movement and other important areas of their brain function, as well as their school progress, blood pressure, lung function and general health and growth. EXPECTED OUTCOMES OF THE RESEARCH If we find important improvements in health outcomes at school-age in children exposed to repeat corticosteroids, without any substantial couterbalancing adverse effects, repeat steroids will be recommended standard therapy in women who are likely to give birth to their baby very early. This will lead to a reduction in the burden of ill health.

我们最近在澳大利亚和新西兰完成了一项大型临床试验，对可能过早分娩的妇女（妊娠34周前）重复使用产前皮质类固醇。我们已经能够证明，出生前重复使用皮质类固醇可显著降低婴儿出生后发生呼吸困难的风险，从41.4%降至32.8%。然而，我们不确定这一潜在的重要改进是否会随着儿童年龄的增长和达到学龄而转化为更好的结果。由于有许多例子表明，在出生时给予的治疗有一些短期的好处，但长期的危害很大，我们必须尽可能肯定，一个小的健康领域的任何进步不会被其他健康领域的劣势所抵消。鉴于早期非随机研究的相互矛盾的报告，找出重复产前皮质类固醇尤为重要。我们计划评估1085名早期临床试验的幸存者，这些试验是在他们处于学龄早期时重复使用产前皮质类固醇。我们将评估他们的运动和大脑功能的其他重要领域，以及他们的学习进度，血压，肺功能和一般健康和成长。研究的预期结果如果我们发现暴露于重复皮质类固醇的儿童在学龄期的健康结果有重要的改善，而没有任何实质性的反平衡不良反应，重复类固醇将被推荐为可能早产的女性的标准治疗。这将减少健康不良的负担。