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

早产婴儿需要帮助呼吸才能生存的风险很高。在早产之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持续7天。正因为如此，对于那些仍然有早产风险的妇女来说，在产后7天重复使用产前类固醇的剂量是一种趋势。目前还没有正式的评估是否重复产前皮质类固醇的剂量是有益还是有害的。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使用糖皮质激素对两岁儿童的影响（如果有的话），如果怀孕少于32周，7天或更长时间前接受糖皮质激素治疗，并且被认为仍有早产风险的妇女有资格参加试验。女性被随机分配到两个治疗组中的一个。一半的妇女将接受每周一次的肌肉注射皮质类固醇，直到出生或怀孕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。机会将决定女性接受何种治疗。在这项研究中，所有存活到2岁矫正年龄的儿童都将被评估，看他们在健康、生长和发育方面是否有任何问题。我们将特别评估他们走路、说话、理解、看和听的能力。该试验将通过比较出生后和住院期间对婴儿健康的短期影响，以及对儿童后来的健康、生长和发育的影响，来评估产前重复剂量的皮质类固醇对有早产风险的婴儿是否有帮助。将对这些儿童进行产前皮质类固醇重复剂量的经济评估。

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.