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

Results from this single-arm, multi-center clinical study are intended to evaluate the safety
and effectiveness of the Babylog VN500 device in high frequency oscillatory ventilation
(HFOV) mode in very low birth weight (VLBW) neonates of 23 to 30 weeks' gestational age (400
g to 1200 g, inclusive) with documented respiratory distress requiring invasive respiratory
support. The safety will be determined by evaluating the rate of subjects alive at Day 32 and
free of Grade III/IV intraventricular hemorrhage (IVH) or cystic periventricular
leukomalacia. Evaluation of the Alveolar-arterial (A-a) gradient 12 hours after start of
ventilation will account for the effectiveness.

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