TY - JOUR
T1 - Early high-frequency oscillatory ventilation versus synchronized intermittent mandatory ventilation in very low birth weight infants
T2 - A pilot study of two ventilation protocols
AU - Durand, David J.
AU - Asselin, Jeanette M.
AU - Hudak, Mark L.
AU - Aschner, Judy L.
AU - Mcartor, Robert D.
AU - Cleary, John P.
AU - Vanmeurs, Krisa P.
AU - Stewart, Daniel L.
AU - Shoemaker, Craig T.
AU - Wiswell, Thomas E.
AU - Courtney, Sherry E.
N1 - Funding Information:
1This study was presented in part at the Society for Pediatric Research in May 1998 in New Orleans, LA. This study was supported in part by Abbott Laboratories/Ross Products Division, Hamilton Medical, Ballard Medical Products, SensorMedics, the Society for Pediatric Research, the East Bay Neonatology Foundation, and Cooper Hospital/UMC.
PY - 2001
Y1 - 2001
N2 - Objective: To evaluate the feasibility of conducting a prospective, randomized trial comparing early high-frequency oscillatory ventilation (HFOV) to synchronized intermittent mandatory ventilation (SIMV) in very low birth weight (VLBW) premature infants. This pilot study evaluated two ventilator management protocols to determine how well they could be implemented in a multicenter clinical trial. Although this pilot study was not powered to detect differences in outcome, we also collected outcome data. Design: Prospective, multicenter, randomized pilot study. Setting: Seven tertiary-level intensive care nurseries with previous experience with both HFOV and flow-triggered SIMV. Patients: Fifty infants weighing 501 to 1200 g, less than 4 hours of age, who had received one dose of surfactant and required ventilation with mean airway pressure ≥6 cm H2O and F1O2 ≥0.25, and had an anticipated duration of ventilation greater than 24 hours. Interventions: Patients were stratified by birth weight and prenatal steroid status, then randomized to either HFOV or SIMV with tidal volume monitoring. Ventilator management for patients in both study arms was strictly governed by protocols that included optimizing lung inflation and blood gases, weaning strategies, and extubation criteria. Measurements: Data were collected using the tools planned for the larger collaborative study. Protocol compliance was closely monitored, with successive changes in the protocol made as necessary to improve clarity and increase compliance. The incidence of major neonatal adverse outcomes was recorded. Main Results: Data are presented for 24 HFOV and 24 SIMV infants (two infants, twins, were withdrawn from the study at parent's request). Nineteen of the 24 HFOV infants and 20 of the 24 SIMV infants survived to 36 weeks corrected age. Age at final extubation for survivors was 16±16 (mean ± SD) days for HFOV infants and 24±24 days for SIMV infants. At 36 weeks corrected age, 14 of the 19 HFOV survivors were extubated and in room air, whereas 5 required supplemental oxygen. In comparison, 6 of the 20 SIMV survivors were extubated and in room air, whereas 14 required supplemental oxygen. Grade III/IV IVH and/or periventricular leukomalacia occurred in 2 HFOV and 2 SIMV patients. Overall compliance with the ventilator protocols was 82% for the SIMV protocol, and 88% for the HFOV protocol. Conclusions: The preliminary outcome data supports conducting the large randomized trial, which began in July of 1998. The protocols for the ventilator management of VLBW infants, both with HFOV and with SIMV were easily implemented and consistently followed, and are presented here.
AB - Objective: To evaluate the feasibility of conducting a prospective, randomized trial comparing early high-frequency oscillatory ventilation (HFOV) to synchronized intermittent mandatory ventilation (SIMV) in very low birth weight (VLBW) premature infants. This pilot study evaluated two ventilator management protocols to determine how well they could be implemented in a multicenter clinical trial. Although this pilot study was not powered to detect differences in outcome, we also collected outcome data. Design: Prospective, multicenter, randomized pilot study. Setting: Seven tertiary-level intensive care nurseries with previous experience with both HFOV and flow-triggered SIMV. Patients: Fifty infants weighing 501 to 1200 g, less than 4 hours of age, who had received one dose of surfactant and required ventilation with mean airway pressure ≥6 cm H2O and F1O2 ≥0.25, and had an anticipated duration of ventilation greater than 24 hours. Interventions: Patients were stratified by birth weight and prenatal steroid status, then randomized to either HFOV or SIMV with tidal volume monitoring. Ventilator management for patients in both study arms was strictly governed by protocols that included optimizing lung inflation and blood gases, weaning strategies, and extubation criteria. Measurements: Data were collected using the tools planned for the larger collaborative study. Protocol compliance was closely monitored, with successive changes in the protocol made as necessary to improve clarity and increase compliance. The incidence of major neonatal adverse outcomes was recorded. Main Results: Data are presented for 24 HFOV and 24 SIMV infants (two infants, twins, were withdrawn from the study at parent's request). Nineteen of the 24 HFOV infants and 20 of the 24 SIMV infants survived to 36 weeks corrected age. Age at final extubation for survivors was 16±16 (mean ± SD) days for HFOV infants and 24±24 days for SIMV infants. At 36 weeks corrected age, 14 of the 19 HFOV survivors were extubated and in room air, whereas 5 required supplemental oxygen. In comparison, 6 of the 20 SIMV survivors were extubated and in room air, whereas 14 required supplemental oxygen. Grade III/IV IVH and/or periventricular leukomalacia occurred in 2 HFOV and 2 SIMV patients. Overall compliance with the ventilator protocols was 82% for the SIMV protocol, and 88% for the HFOV protocol. Conclusions: The preliminary outcome data supports conducting the large randomized trial, which began in July of 1998. The protocols for the ventilator management of VLBW infants, both with HFOV and with SIMV were easily implemented and consistently followed, and are presented here.
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U2 - 10.1038/sj.jp.7210527
DO - 10.1038/sj.jp.7210527
M3 - Article
C2 - 11533838
AN - SCOPUS:17944382820
SN - 0743-8346
VL - 21
SP - 221
EP - 229
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 4
ER -