BACKGROUND:Mechanical ventilation and surfactants are the standard treatment of preterm respiratory distress syndrome (RDS). The effects of the primary ventilation model on bronchopulmonary dysplasia (BPD) and long-term neurodevelopment outcomes are controversial. The purpose of this study was to compare the efficacy and safety of high-frequency oscillatory ventilation (HFOV) and synchronized intermittent mandatory ventilation plus pressure support ventilation (SIMV-PSV) in preterm infants with severe RDS. METHODS: A total of 366 eligible preterm infants were randomly assigned to treatment with HFOV (n = 184) or SIMV-PSV (n = 182). Surfactant was applied if PaO2/FIO2 was < 200 mm Hg after 2 hours of ventilation. Primary outcomes were mortality or incidence of BPD. Secondary outcomes were duration of ventilation and hospitalization, surfactant requirements, pneumothorax, retinopathy of prematurity ≥ stage 2, and neurodevelopment at 18 months of corrected age. RESULTS:Survival and complete outcome data were available for 288 infants at 18 months of corrected age. The incidence of death or BPD was significantly higher in the SIMV-PSV group (P = .001). The duration of mechanical ventilation and hospitalization was shorter and the incidence of surfactant requirement and retinopathy of prematurity was lower in the HFOV group (P < .001, P = .002, P = .04, respectively). Moderate or severe neurological disability was less frequent in the HFOV group than in the SIMV-PSV group at 18 months (P = .03). The combination of HFOV and surfactant dramatically reduced negative outcomes in preterm infants with severe RDS. CONCLUSIONS: Initial ventilation with HFOV in preterm infants with severe RDS reduces the incidence of death and BPD, and improves long-term neurodevelopment outcomes. (ClinicalTrials.gov NCT01496508).
RCT Entities:
BACKGROUND: Mechanical ventilation and surfactants are the standard treatment of preterm respiratory distress syndrome (RDS). The effects of the primary ventilation model on bronchopulmonary dysplasia (BPD) and long-term neurodevelopment outcomes are controversial. The purpose of this study was to compare the efficacy and safety of high-frequency oscillatory ventilation (HFOV) and synchronized intermittent mandatory ventilation plus pressure support ventilation (SIMV-PSV) in preterm infants with severe RDS. METHODS: A total of 366 eligible preterm infants were randomly assigned to treatment with HFOV (n = 184) or SIMV-PSV (n = 182). Surfactant was applied if PaO2/FIO2 was < 200 mm Hg after 2 hours of ventilation. Primary outcomes were mortality or incidence of BPD. Secondary outcomes were duration of ventilation and hospitalization, surfactant requirements, pneumothorax, retinopathy of prematurity ≥ stage 2, and neurodevelopment at 18 months of corrected age. RESULTS: Survival and complete outcome data were available for 288 infants at 18 months of corrected age. The incidence of death or BPD was significantly higher in the SIMV-PSV group (P = .001). The duration of mechanical ventilation and hospitalization was shorter and the incidence of surfactant requirement and retinopathy of prematurity was lower in the HFOV group (P < .001, P = .002, P = .04, respectively). Moderate or severe neurological disability was less frequent in the HFOV group than in the SIMV-PSV group at 18 months (P = .03). The combination of HFOV and surfactant dramatically reduced negative outcomes in preterm infants with severe RDS. CONCLUSIONS: Initial ventilation with HFOV in preterm infants with severe RDS reduces the incidence of death and BPD, and improves long-term neurodevelopment outcomes. (ClinicalTrials.gov NCT01496508).
Authors: Benjamin W Ackermann; Daniel Klotz; Roland Hentschel; Ulrich H Thome; Anton H van Kaam Journal: Pediatr Res Date: 2022-02-08 Impact factor: 3.756
Authors: Markus Waitz; Corinna Engel; Rolf Schloesser; Ulrich Rochwalsky; Sascha Meyer; Alexander Larsen; Paul Hoffmann; Michael Zemlin; Bettina Bohnhorst; Corinna Peter; Marc Hoppenz; Thomas Pabst; Klaus-Peter Zimmer; Axel R Franz; Christoph Haertel; Eric Frieauff; Julia Sandkötter; Katja Masjosthusmann; Philipp Deindl; Dominique Singer; Melanie Heidkamp; Annesuse Schmidt; Harald Ehrhardt Journal: Trials Date: 2020-10-01 Impact factor: 2.279