Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates

Inclusion Criteria: * Gestational Age between 23 to 30 weeks; within first 4 days of life * very low birth weight between 400 g and 1200 g, inclusive * 5-minute Apgar score \>3 * documented respiratory distress requiring invasive respiratory Support * A priori: primary intention for either HFOV or high-frequency jet ventilation OR Severity of Illness: mechanical ventilation with a fraction of inspired oxygen of ≥ 0.25% and a mean airway pressure of ≥ 7 cm H2O, more than 2 hours after an initial dose of surfactant required and clinical care team believes that treatment with HFOV is indicated * anticipated availability of investigational device at the study center before screening for enrollment * written informed consent to participate in the study provided by a parent or legal guardian Exclusion Criteria: * anticipation to require intubation and mechanical ventilation for less than 12 hours * previous exposure to any mechanical ventilation for ≥ 96 hours before planned HFOV treatment * obvious chromosomal or major congenital abnormalities involving the respiratory tract or upper airway * known congenital heart disease, excluding Patent Ductus Arteriosus (PDA), ventricular-septal defect, or atrial-septal defect * pre-existing air leak, including pneumothorax, pneumomediastinum, pneumopericardium, or extensive bilateral Pulmonary Interstitial Emphysema (PIE) * severe metabolic acidosis with a base deficit of ≥ 15 before planned HFOV treatment * severe hypotension (a mean blood pressure more than 2 standard deviations below the mean neonate's birth weight despite a total combined dose of dopamine, dobutamine, or both, of 20 µg(kg/min) * moribund subject not expected to survive, or a subject in whom there is a decision to limit care * currently receiving or previous treatment with inhaled nitric oxide * currently receiving or previous treatment with corticosteroids specifically for BPD prevention * evidence of severe sepsis (neutropenia, severe hypotension, shock) * evidence of Nectrotising Enterocolitis (NEC), defined as Modified Bell's Stage II or greater * documented Grade III/IV intraventricular hemorrhage * current enrollment in another Investigational Device Exemption or Investigational New Drug clinical study where treatment, testing, or follow-up may interfere with the results