ASSOCIATIONS BETWEEN USE OF ANTENATAL CORTICOSTEROIDS AND NEONATAL OUTCOMES WITHIN THE EXOSURF NEONATAL TREATMENT INVESTIGATIONAL NEW DRUG PROGRAM

Significant reductions in the incidence of respiratory distress syndrome (RDS), mortality, and necrotizing enterocolitis (NEC) were observed in premature infants born of mothers who received antenatal corticosteroid therapy in a series of randomized trials assessed by meta-analysis.(1,2) Maher et al.(3) recently reported reductions in the incidence of RDS and in the number of days that infants received mechanical ventilation after steroid use on the basis of observational data collected at five centers between 1982 and 1986, prior to broad availability of surfactant replacement therapy. Farrell et al.(4) and Kwong et al.(5) assessed infants after antenatal corticosteroid exposure and surfactant therapy and noted reductions in both the incidence and severity of RDS, and Kwong et al.(5) also reported a decrease in the length of hospital stay in infants exposed to both therapies. Jobe et al.(6) evaluated a database from several clinical trials of surfactant and found a significant reduction in mortality in the group that received both surfactant and corticosteroids compared with groups that received neither or only one of the therapies. Despite the documented benefits of antenatal steroid use, their utilization is low. Reasons cited for this low utilization include the perception that benefits may not be achieved if delivery occurs before 24 hours have elapsed following steroid initiation and the perception that surfactant replacement therapy may compensate for lack of steroid therapy. The Exosurf Neonatal (colfosceril palmitate, cetyl alcohol, and tyloxapol for endotracheal suspension) Treatment Investigational New Drug (IND) program afforded the opportunity to evaluate the associations between use of antenatal steroids and neonatal outcomes in a large observational experience under conditions reflective of current medical practice. Initial analyses have been presented elsewhere,(7) The new analyses presented here were undertaken in preparation for the Consensus Development Conference on the Effects of Corticosteroids for Fetal Maturation on Perinatal Outcomes in collaboration with analyses of the observational databases of the National Institute of Child Health and Development Neonatal Research Network,(8) the Vermont-Oxford Trials Network,(9) Ross Laboratories surfactant clinical trials,(10) and our surfactant clinical trials,(11) which are also presented in this supplement.