Department of Newborn and Developmental Paediatrics, Centre for Mother, Infant, and Child Research, Sunnybrook Health Sciences Centre, M4-233 2075 Bayview Ave Toronto, Ontario, M4N 3M5, Canada.
Pediatrics. 2010 Nov;126(5):e1045-55. doi: 10.1542/peds.2010-0857. Epub 2010 Oct 18.
The aim of this study was to determine the effects of repeated courses of prenatal corticosteroid therapy versus placebo on death or neurologic impairment among the children enrolled in the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, at 18 to 24 months of age.
A total of 2305 infants were eligible for follow-up evaluation; 2104 infants (1069 in the prenatal corticosteroid therapy group and 1035 in the placebo group) were monitored. The primary outcome was death or neurologic impairment, defined as either cerebral palsy or cognitive delay, at 18 to 24 months of age. The secondary outcomes were measurements of growth (height, weight, and head circumference).
Children exposed to multiple courses of prenatal corticosteroid therapy had similar rates of death or neurologic impairment, compared with children exposed to placebo (148 children [13.8%] vs 142 children [13.7%]; odds ratio: 1.001[95% confidence interval: 0.75-1.30]; P = .95). They had a mean weight of 11.94 kg, compared with 12.14 kg in the placebo group (P = .04), a mean height of 85.51 cm, compared with 85.46 cm (P = .87), and a mean head circumference of 48.18 cm, compared with 48.25 cm (P = .45).
Multiple courses of prenatal corticosteroid therapy, given every 14 days, did not increase or decrease the risk of death or neurologic impairment at 18 to 24 months of age, compared with a single course of prenatal corticosteroid therapy. Continued follow-up monitoring of these children is necessary to assess neurobehavioral function, school performance, and possible susceptibility to disease.
本研究旨在确定在多次产前皮质类固醇治疗与安慰剂治疗的儿童中,在 18 至 24 个月时,与单次产前皮质类固醇治疗相比,重复疗程的产前皮质类固醇治疗对死亡或神经损伤的影响。
共有 2305 名婴儿符合随访评估条件;2104 名婴儿(皮质类固醇治疗组 1069 名,安慰剂组 1035 名)接受监测。主要结局是 18 至 24 个月时的死亡或神经损伤,定义为脑瘫或认知延迟。次要结局是生长(身高、体重和头围)的测量。
与接受安慰剂治疗的儿童相比,接受多次产前皮质类固醇治疗的儿童的死亡率或神经损伤率相似(148 名儿童[13.8%]与 142 名儿童[13.7%];比值比:1.001[95%置信区间:0.75-1.30];P =.95)。他们的平均体重为 11.94 公斤,而安慰剂组为 12.14 公斤(P =.04),平均身高为 85.51 厘米,而安慰剂组为 85.46 厘米(P =.87),平均头围为 48.18 厘米,而安慰剂组为 48.25 厘米(P =.45)。
与单次产前皮质类固醇治疗相比,每 14 天给予多次产前皮质类固醇治疗并未增加或降低 18 至 24 个月时死亡或神经损伤的风险。需要对这些儿童进行持续的随访监测,以评估神经行为功能、学校表现和可能的疾病易感性。