A Clinical Study to Evaluate the Safety and Effectiveness of the Infinity Acute Care System Workstation Neonatal Care Babylog VN500 Device in High Frequency Oscillatory Ventilation (HFOV) Mode in Very Low Birth Weight (VLBW) Neonates
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome In Premature Infants
- Sponsor
- Draeger Medical Systems, Inc.
- Enrollment
- 225
- Locations
- 14
- Primary Endpoint
- Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive respiratory support in the treatment of respiratory distress.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
Time Frame: Day 32 +/- 10 days gestational age
Papile's grading on cranial ultrasound
Alveolar-arterial (A-a) Gradient change
Time Frame: 12 hours after onset of HFOV treatment
A-a Gradient as measured by arterial blood gas after onset of Treatment with the Babylog VN500 in HFOV mode
Secondary Outcomes
- Freedom from study-defined serious adverse events(during Treatment Phase (up to 14 days))
- Device failure rate(during Treatment Phase (up to 14 days))
- Neurodevelopment assessment(22 - 24 months corrected age)
- Change of partial carbon dioxide pressure (PaCO2)(2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment)
- Relationship between tidal volume high frequency (Vthf) set and Vthf observed(2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment)
- Stability of Vthf observed and carbon dioxide diffusion (DCO2) coefficient monitoring during high frequency oscillation over time(first 48 hours of HFOV treatment)
- Freedom from Bronchopulmonary Dysplasia (BPD)(36 week's corrected age)
- Length and Type of Respiratory Support(participants will be followed for the duration of hospital stay, an expected average of 14 weeks)
- Neonatal survival(participants will be followed for the duration of hospital stay, an expected average of 14 weeks)