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A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Our placebo controlled trial of multiple courses of ACS, every 14 days, found no benefit. Infants exposed to multiple courses of ACS weighed less and had smaller head circumferences. (Lancet 2008; 372: 2143-51). The secondary outcome of this study was to determine if there was a difference in the risk of death or neurological impairment at 18-24 months of age.
1858 women were randomized to receive multiple courses of ACS vs. placebo, every 14 days, until 33 6/7 weeks or delivery whichever came first. The primary outcome was a neonatal composite outcome. The secondary outcome was death or neurodevelopmental impairment defined as cerebral palsy or abnormal cognitive development. Abnormal cognitive development was defined as a score of < 70 on the Bayley Scale of Infant Development-II or comparable neurocognitive assessment or a delayed mental developmental age in the absence of a standardized assessment. Biometry was also assessed.
Of the original 2305 infants/foetuses, a total of 2104 (91.3%) were assessed at 18-24 months of age. The risk of death or neurodevelopmental impairment was similar between groups (148 [13.8%] ACS vs. 142 [13.7%] placebo group; OR 1.001; 95% CI 0.75-1.31, p=0.95). Toddlers exposed to multiple courses of ACS weighed less than those exposed to placebo (11.94g ACS vs. 12.14g placebo; risk difference −0.2; 95% CI −0.38, -0.006; p=0.04).
Administration of multiple courses of ACS, every 14 days, did not lead to a difference in death or neurologic impairment at 18-24 months of age. However, children exposed to multiple courses of ACS weighed less. Longer term follow-up studies are required (ClinicalTrials.gov number, NCT 00187382).