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2: Multiple Courses of Antenatal Corticosteroids for preterm birth study: 5-year outcomes (MACS-5)

      Objective

      Recent trials of repeated courses of antenatal corticosteroid therapy show some benefits in the reduction of respiratory distress but have raised concerns regarding potential harm. Long-term outcomes at 2 years of age have shown no benefit in the neurodevelopmental status of the children. The aim of this study was to determine the effects of repeated courses of antenatal corticosteroid therapy versus placebo on death or neurodevelopmental impairment among the children enrolled in the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) at 5 years of age.

      Study Design

      The primary outcome was a combined outcome of death or survival with a severe disability in at least one of the following domains: non-ambulatory cerebral palsy, blindness in at least one eye, deafness, need for visual or hearing aids, neuro-cognitive disability at 5 years of age. Five year follow-up was conducted from 2006-2012 in 52 of the initial 80 centers worldwide, where 2141 of 2304 fetuses/infants (93%) were enrolled. A total of 1728(80.7%) had adequate data for the main outcome at 5 years of age.

      Results

      There was no significant difference between the two treatment groups in the risk of death or neurodevelopmental difficulty: 217 (24.9%) of the 873 in the repeat courses group vs. 210 (24.6%) of the 855 in the placebo group, [odds ratio 1.025, 95% confidence interval 0.81-1.29, p=0.83]. The rates of death or individual neurodevelopmental difficulties did not differ significantly between the two groups.

      Conclusion

      Multiples courses of antenatal corticosteroid therapy given, every 14 days, do not increase or decrease the risk of death or neurodevelopmental difficulties by 5 years of age compared with a single course. Because there has been no clear benefit seen in the neonatal period, as well as at 2 and 5 years of age, this approach of antenatal corticosteroids is not recommended for routine use. Future research may be warranted for a more specified use of repeated courses of antenatal corticosteroids.
      Tabled 1*Apart from a death, child may have more than 1 disability; **10 cases were reviewed by an adjudication committee to determine whether they met the primary outcome; 5 cases were determined to have met the primary outcome.
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