To determine the efficacy and safety of high-frequency oscillatory ventilation (HFOV) compared to conventional ventilation (CV) for the treatment of respiratory failure in term and near-term infants in Colombia.
Eligible infants with moderate to severe respiratory failure were randomized to early treatment with CV or HFOV. Ventilator management and general patient care were standardized. The main outcome was neonatal death or pulmonary air leak.
A total of 119 infants were enrolled (55 in the HFOV group; 64 in the CV group) during the study period. Six infants in the HFOV group (11%) and two infants in the CV group (3%) developed the primary outcome (RR: 3.6, 95% CI: 0.8–16.9). Five infants in the HFOV group (9%) and one infant in the CV (2%) died before 28 days of life (RR: 5.9 CI: 0.7–48.2). Secondary outcomes were similar between groups.
HFOV may not be superior to CV as an early treatment for respiratory failure in this age group. Standardization of ventilator management and general patient care may have a greater impact on the outcome in Colombia than mode of ventilation.
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We gratefully acknowledge the contribution of the research assistants from each participating center for data collection as well as the respiratory therapists and nursing staff for making this study possible. We thank Gennie Bose for supporting nurse staff training in Colombia and Dr. Juan Gabriel Ruiz for his involvement in the SRC and the interim analysis, and Esperanza Peña for helping us coordinate this study. We also thank Dr. Diane Marshall for proof reading this manuscript and Dr. Reese Clark for his contribution during the initial design of this study and review of the manuscript.
Research supported in part by SensorMedics Corporation and the American Lung Association of North Carolina.
Supplementary Information accompanies the paper on the Journal of Perinatology website (http://www.nature.com/jp)
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Rojas, M., Lozano, J., Rojas, M. et al. Randomized, Multicenter Trial of Conventional Ventilation Versus High-Frequency Oscillatory Ventilation for the Early Management of Respiratory Failure in Term or Near-Term Infants in Colombia. J Perinatol 25, 720–724 (2005). https://doi.org/10.1038/sj.jp.7211386
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