The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age

Keller, R. L.; Eichenwald, E. C.; Hibbs, A. M.; Rogers, E. E.; Wai, K. C.; Black, D. M.; Ballard, P. L.; Asselin, J. M.; Truog, W. E.; Merrill, J. D.; Mammel, M. C.; Steinhorn, R. H.; Ryan, R. M.; Durand, D. J.; Bendel, C. M.; Bendel-Stenzel, E. M.; Courtney, S. E.; Dhanireddy, R.; Hudak, M. L.; Koch, F. R.; Mayock, D. E.; McKay, V. J.; Helderman, J.; Porta, N. F.; Wadhawan, R.; Palermo, L.; Ballard, R. A.

J Pediatr. 2017 Jan 20; 183:19-25 e2

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 (/=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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