Cindy McEvoy1,2, Diane Schilling1, Patricia Spitale1, Jean O'Malley3, Susan Bowling2, Manuel Durand4. 1. Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, Oregon. 2. Department of Pediatrics, Sacred Heart Hospital, Pensacola, Florida. 3. Public Health and Preventive Medicine, Oregon Health & Science University, Portland, Oregon. 4. Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, California.
Abstract
BACKGROUND/ OBJECTIVE: Our objective was to obtain follow-up pulmonary function testing and assessment of clinical respiratory outcomes, at 1-2 years, in preterm infants whose mothers were randomized to a single rescue course of antenatal steroids (AS) versus placebo. METHODS: Follow-up of a randomized, double-blinded trial. In the original trial pregnant women ≥14 days after initial course of AS were randomized to rescue AS or placebo. Pulmonary function testing and a standardized respiratory questionnaire were obtained at 1-2 years of corrected age. Respiratory compliance (Crs) was measured with the single-breath occlusion and functional residual capacity (FRC) with the nitrogen washout method. Analysis was by intention-to-treat. RESULTS: A total of 96 (87%) of available survivors were administered a respiratory questionnaire. Seventy-seven percent of available patients had pulmonary function testing performed. There was no significant difference between groups in incidence of wheezing, asthma, respiratory syncytial virus infection, respiratory readmissions, use of bronchodilators or other medications, or in measurements of pulmonary function. There was also no significant difference in corrected age at study, race, gender, or length at the time of pulmonary function testing. Infants in the rescue group had a comparable mean FRC (249.4 mL vs 246.2 mL; adjusted 95%CI for difference -15.45, 38.20; P = 0.37) versus placebo. There were no differences in tidal volume or Crs. CONCLUSION: A rescue course of AS significantly increases Crs within 72 h of age and decreases oxygen need in newborn infants, without an adverse impact on pulmonary function or clinical respiratory outcomes at 1-2 years of age [NCT00669383].
RCT Entities:
BACKGROUND/ OBJECTIVE: Our objective was to obtain follow-up pulmonary function testing and assessment of clinical respiratory outcomes, at 1-2 years, in preterm infants whose mothers were randomized to a single rescue course of antenatal steroids (AS) versus placebo. METHODS: Follow-up of a randomized, double-blinded trial. In the original trial pregnant women ≥14 days after initial course of AS were randomized to rescue AS or placebo. Pulmonary function testing and a standardized respiratory questionnaire were obtained at 1-2 years of corrected age. Respiratory compliance (Crs) was measured with the single-breath occlusion and functional residual capacity (FRC) with the nitrogen washout method. Analysis was by intention-to-treat. RESULTS: A total of 96 (87%) of available survivors were administered a respiratory questionnaire. Seventy-seven percent of available patients had pulmonary function testing performed. There was no significant difference between groups in incidence of wheezing, asthma, respiratory syncytial virus infection, respiratory readmissions, use of bronchodilators or other medications, or in measurements of pulmonary function. There was also no significant difference in corrected age at study, race, gender, or length at the time of pulmonary function testing. Infants in the rescue group had a comparable mean FRC (249.4 mL vs 246.2 mL; adjusted 95%CI for difference -15.45, 38.20; P = 0.37) versus placebo. There were no differences in tidal volume or Crs. CONCLUSION: A rescue course of AS significantly increases Crs within 72 h of age and decreases oxygen need in newborn infants, without an adverse impact on pulmonary function or clinical respiratory outcomes at 1-2 years of age [NCT00669383].
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