Neurodevelopmental outcomes after late preterm antenatal corticosteroids: the alps follow-up study

The antenatal late preterm steroids (ALPS) randomized trial noted decreased short-term neonatal respiratory morbidity after antenatal exposure to betamethasone (BMZ) compared with placebo. We evaluated whether administration of late preterm (34-36 weeks) corticosteroids affected childhood neurodevelopmental outcomes. Prospective, follow-up study of children of participants enrolled in the ALPS trial. All original subjects who consented to future contact were eligible if their child was ≥6 years old. Parent/caregiver consent and child assent were obtained. Cognitive testing was performed by a certified psychologist using the Differential Ability Scales, 2nd Edition (DAS-II) core components of the general conceptual ability (GCA) including verbal, non-verbal reasoning, and spatial ability. The primary outcome, the proportion of GCA scores < 85 (-1 standard deviation), was assessed by trial treatment assignment, BMZ or placebo. Secondary outcomes included the Gross Motor Function Classification System (GMFCS) level, the Social Responsiveness Scale (SRS) >65, and Child Behavior Checklist (CBCL) scores. Univariable and multivariable analyses were performed, the latter adjusting for pre-specified variables known to be associated with the primary outcome. Sensitivity analyses modeled the outcome for those lost to follow-up (LTF). Of 2,831 children from the ALPS trial, 1,026 were enrolled and 949 completed the DAS-II, (479 BMZ, 470 placebo). Maternal and neonatal characteristics were similar between groups aside from neonatal hypoglycemia, which was more common in the BMZ group (Table 1). There was no difference in the primary outcome, GCA < 85, with 82 (17.1%) for BMZ and 87 (18.5%) for placebo (adjusted relative risk 0.94; 95% CI 0.73,1.22). There were no differences in the GMFCS, SRS, or CBCL (Table 2). Sensitivity analyses assuming that all participants LTF either had or did not have the adverse primary outcome also found no differences by treatment assignment. Administration of late preterm antenatal corticosteroids did not affect childhood neurodevelopmental outcomes.