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1: Antenatal Late Preterm Steroids (ALPS): a randomized trial to reduce neonatal respiratory morbidity

      Objective

      Infants born in the late preterm period are more susceptible to adverse neonatal outcome, particularly respiratory morbidity, than those born at term. Our objective was to assess whether administration of betamethasone (BMZ) in pregnancies at risk for late preterm delivery would decrease respiratory and other neonatal morbidities.

      Study Design

      We performed a multicenter, double-blind, randomized controlled trial at 17 tertiary medical centers from 10/2010 to 2/2015. Women with non-anomalous, singleton gestations at high risk for indicated or spontaneous late preterm delivery (34 0/7 to 36 6/7 weeks) were randomized to 12 mg betamethasone intramuscularly or a matching placebo. A second dose was given at 24 hours if the patient was undelivered. The primary outcome was a composite of respiratory morbidity occurring by the first 72 hours of life including continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC) for ≥2 hours, oxygen (O2) requirement with FiO2 of ≥30% for ≥4 hours, any mechanical ventilation or perinatal death. A more severe respiratory morbidity extending O2 requirement to ≥24 hours and CPAP/HFNC to ≥12 hours was a pre-specified secondary endpoint. Charts of all infants admitted to special care were centrally reviewed to verify respiratory outcomes. Our required sample size was 2,800.

      Results

      2,831 patients were randomized (1402 placebo, 1429 BMZ). Of those, 60% received 2 doses and 65.2% were <36 weeks. There was a significant reduction in the incidence of the primary outcome in the BMZ group compared with placebo (Table). Severe respiratory morbidity, TTN and surfactant use were also reduced. There were no significant differences in the incidence of chorioamnionitis or neonatal sepsis, but hypoglycemia was more common in the BMZ group.

      Conclusion

      Administration of betamethasone for women at risk for late preterm delivery was associated with decreased serious neonatal respiratory morbidity and the need for surfactant.
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