School-Age Outcomes of Very Preterm Infants and Antenatal Magnesium Sulphate Therapy - A Randomised Controlled Trial

极早产儿的学龄结局和产前硫酸镁治疗 - 随机对照试验

• 批准号: nhmrc : 350326
• 负责人: A/Pr Ross Haslam
• 金额: $ 45.01万
• 依托单位: The University of Melbourne
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2005
• 资助国家: 澳大利亚
• 起止时间: 2005-01-01 至 2007-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/school-age-outcomes-controlled-trial/99245
• 关键词: Age; Outcomes; Very; Preterm; Infants

Despite recent major advances in care around the time of birth that have led to large increases in the survival rates for very preterm babies, the rate of adverse long-term health problems has not diminished in survivors, and remains too high compared with children not born very preterm. In particular they have higher rates of substantial problems with the way their brain works, particularly affecting their movement, vision, hearing, thinking and talking. We have just concluded a large clinical trial in Australia and New Zealand of magnesium sulphate which was given to mothers who were likely to deliver their baby too early (before 30 weeks of pregnancy). We have been able to show, for the first time, that magnesium sulphate was able to halve the rate of substantial problems with movement in 2 year old survivors, from 6% to 3%. 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. We plan to assess the 1061 survivors from our earlier clinical trial of magnesium sulphate therapy at ages from 7-8 years, when they are at school. We will assess their movement and other important areas of their brain function, as well as their school progress and general health and growth. If we find important improvements in health at school-age of these children caused by magnesium sulphate therapy, without any substantial counterbalancing side-effects, magnesium sulphate will probably become standard therapy in mothers who are likely to deliver their baby very early. This will lead to a reduction in the burden of illness in the community caused by being born too early.

尽管最近在出生时的护理方面取得了重大进展，导致早产儿的存活率大幅提高，但幸存者的不良长期健康问题的发生率并没有减少，与非早产儿相比仍然过高。特别是，他们的大脑工作方式有更高的实质性问题，特别是影响他们的运动，视觉，听觉，思维和说话。我们刚刚在澳大利亚和新西兰完成了一项大型的硫酸镁临床试验，该试验是针对那些可能过早分娩的母亲（怀孕30周之前）。我们已经能够表明，第一次，硫酸镁能够减少一半的利率与运动的重大问题，在2岁的幸存者，从6%到3%。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。我们计划评估1061名来自我们早期硫酸镁治疗临床试验的幸存者，他们的年龄在7-8岁之间，当时他们还在上学。我们将评估他们的运动和他们大脑功能的其他重要领域，以及他们的学业进展和一般健康和成长。如果我们发现硫酸镁治疗对学龄儿童的健康有重要的改善，而没有任何实质性的抵消副作用，硫酸镁可能会成为可能早产的母亲的标准治疗。这将导致社区因过早出生而造成的疾病负担减少。