Repeated Prenatal Corticosteroids: effects on childhood development, behaviour, growth and health

重复产前皮质类固醇：对儿童发育、行为、生长和健康的影响

• 批准号: nhmrc : 349459
• 负责人: A/Pr Ross Haslam
• 金额: $ 17.73万
• 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: 2005
• 资助国家: 澳大利亚
• 起止时间: 2005-01-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/repeated-prenatal-corticosteroids-growth-health/83145
• 关键词: Repeated; Prenatal; Corticosteroids; effects; childhood

Infants born preterm are at high risk of needing help with their breathing to survive. Corticosteroids given to the mother prior to preterm birth can substantially reduce these risks, although the beneficial effects of these drugs only seem to last seven days. Because of this there has been a tendancy to repeat the dose of prenatal steroids after seven days in women who remain at continued risk of very preterm birth. There has been no formal assessment of whether or not repeating the dose of prenatal corticosteroids is beneficial or harmful. In this clinical trial we will test what effect, if any, repeat doses of corticosteroids given to women who remain at risk of preterm birth, have on children at the age of two years Women are eligible for the trial if at of less than 32 weeks of pregnancy, they have received corticosteroids seven or more days ago, and they are considered to be at continued risk of preterm birth. Women are randomised to one of the two treatment groups. Half the women will receive a weekly intramuscular injection of corticosteroids up to the time of birth or 32 weeks gestation, whichever is earlier, whilst the risk of very preterm birth remains. The other half of the women will receive a saline placebo injection. Chance will decide which treatment the women receives. In this study all children who survive to 2 years corrected age will be assessed to see if they have any problems with their health, growth and development. In particular we will assess how well they can walk, talk, understand, see and hear. The trial will be able to assess whether repeat doses of prenatal corticosteroids are helpful or not for infants at risk of being born very preterm by comparing the short term effects on infant health after birth and whilst in hospital with the effects on the child's later health, growth and development. An economic assessment of repeat doses of prenatal corticosteroids will be made in these children.

早产儿需要呼吸帮助才能生存的风险很高。在早产前给予母亲皮质类固醇可以大大降低这些风险，尽管这些药物的有益效果似乎只能持续7天。正因为如此，有一种趋势，即在持续存在极早产风险的妇女中，在7天后重复使用产前类固醇。目前还没有正式的评估是否重复剂量的产前皮质类固醇是有益的或有害的。在这项临床试验中，我们将测试对仍有早产风险的妇女重复给予皮质类固醇对2岁以下儿童的影响（如果有的话）。如果怀孕不到32周，她们在7天或更长时间前接受了皮质类固醇，并且她们被认为有持续的早产风险，则有资格参加这项试验。女性被随机分配到两个治疗组之一。一半的妇女将接受每周肌肉注射皮质类固醇，直至出生或妊娠32周，以较早者为准，同时极早产的风险仍然存在。另一半女性将接受生理盐水安慰剂注射。机会将决定妇女接受何种待遇。在这项研究中，将对所有存活至2岁矫正年龄的儿童进行评估，以确定他们的健康，生长和发育是否存在任何问题。特别是，我们将评估他们的行走、说话、理解、视觉和听觉能力。该试验将能够通过比较出生后和住院期间对婴儿健康的短期影响以及对儿童后期健康、生长和发育的影响，评估重复剂量的产前皮质类固醇是否有助于极早产风险的婴儿。将对这些儿童进行重复产前皮质类固醇剂量的经济评估。