Roberta L Keller1, Eric C Eichenwald2, Anna Maria Hibbs3, Elizabeth E Rogers4, Katherine C Wai5, Dennis M Black6, Philip L Ballard4, Jeanette M Asselin7, William E Truog8, Jeffrey D Merrill7, Mark C Mammel9, Robin H Steinhorn10, Rita M Ryan11, David J Durand7, Catherine M Bendel12, Ellen M Bendel-Stenzel9, Sherry E Courtney13, Ramasubbareddy Dhanireddy14, Mark L Hudak15, Frances R Koch11, Dennis E Mayock16, Victor J McKay17, Jennifer Helderman18, Nicolas F Porta19, Rajan Wadhawan20, Lisa Palermo6, Roberta A Ballard4. 1. Department of Pediatrics, University of California San Francisco, San Francisco, CA. Electronic address: kellerr@peds.ucsf.edu. 2. Department of Pediatrics, University of Texas, Houston, TX. 3. Department of Pediatrics, Case Western Reserve University, Cleveland, OH. 4. Department of Pediatrics, University of California San Francisco, San Francisco, CA. 5. University of California San Francisco School of Medicine, San Francisco, CA. 6. Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA. 7. Department of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA. 8. Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO. 9. Department of Pediatrics, Children's Hospital and Clinics of Minnesota, St Paul and Minneapolis, MN. 10. Department of Pediatrics, Children's National Medical Center, Washington, DC. 11. Department of Pediatrics, Medical University of South Carolina, Charleston, SC. 12. Department of Pediatrics, University of Minnesota, Minneapolis, MN. 13. Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR. 14. Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN. 15. Department of Pediatrics, University of Florida College of Medicine, Jacksonville, FL. 16. Department of Pediatrics, University of Washington, Seattle, WA. 17. Department of Pediatrics, All Children's Hospital, St. Petersburg, FL. 18. Department of Pediatrics, Wake Forest School of Medicine/Forsyth Medical Center, Winston-Salem, NC. 19. Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL. 20. Department of Pediatrics, Florida Hospital for Children, Orlando, FL.
Abstract
OBJECTIVE: To determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control). STUDY DESIGN: Caregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization). Infants were classified for composite outcomes of pulmonary morbidity (no PM, determined in infants with no reported respiratory resource use) and persistent PM (determined in infants with any resource use in ≥3 surveys). RESULTS:Infants (n = 450, late surfactant n = 217, control n = 233) were 25.3 ± 1.2 weeks' gestation and 713 ± 164 g at birth. In the late surfactant group, fewer infants received home respiratory support than in the control group (35.8% vs 52.9%, relative benefit [RB] 1.28 [95% CI 1.07-1.55]). There was no benefit of late surfactant for No PM vs PM (RB 1.27; 95% CI 0.89-1.81) or no persistent PM vs persistent PM (RB 1.01; 95% CI 0.87-1.17). After adjustment for imbalances in baseline characteristics, relative benefit of late surfactant treatment increased: RB 1.40 (95% CI 0.89-1.80) for no PM and RB 1.24 (95% CI 1.08-1.42) for no persistent PM. CONCLUSION: Treatment of newborns of extremely low gestational age with late surfactant in combination withinhaled nitric oxide decreased use of home respiratory support and may decrease persistent pulmonary morbidity. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01022580.
RCT Entities:
OBJECTIVE: To determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control). STUDY DESIGN: Caregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization). Infants were classified for composite outcomes of pulmonary morbidity (no PM, determined in infants with no reported respiratory resource use) and persistent PM (determined in infants with any resource use in ≥3 surveys). RESULTS:Infants (n = 450, late surfactant n = 217, control n = 233) were 25.3 ± 1.2 weeks' gestation and 713 ± 164 g at birth. In the late surfactant group, fewer infants received home respiratory support than in the control group (35.8% vs 52.9%, relative benefit [RB] 1.28 [95% CI 1.07-1.55]). There was no benefit of late surfactant for No PM vs PM (RB 1.27; 95% CI 0.89-1.81) or no persistent PM vs persistent PM (RB 1.01; 95% CI 0.87-1.17). After adjustment for imbalances in baseline characteristics, relative benefit of late surfactant treatment increased: RB 1.40 (95% CI 0.89-1.80) for no PM and RB 1.24 (95% CI 1.08-1.42) for no persistent PM. CONCLUSION: Treatment of newborns of extremely low gestational age with late surfactant in combination with inhaled nitric oxide decreased use of home respiratory support and may decrease persistent pulmonary morbidity. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01022580.
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