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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Respiratory Distress Syndrome In Premature Infants

Intervention / Treatment
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* Device: Babylog VN500 in HFOV Mode


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 30 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Babylog VN500 in HFOV mode<br>Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days. | Device: Babylog VN500 in HFOV Mode<br>* Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL) | Papile's grading on cranial ultrasound | Day 32 +/- 10 days gestational age | 
| Alveolar-arterial (A-a) Gradient change | A-a Gradient as measured by arterial blood gas after onset of Treatment with the Babylog VN500 in HFOV mode | 12 hours after onset of HFOV treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from study-defined serious adverse events | Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport | during Treatment Phase (up to 14 days) | 
| Device failure rate | malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator | during Treatment Phase (up to 14 days) | 
| Neurodevelopment assessment | Bayley Scales of Infant and Toddler Development III | 22 - 24 months corrected age | 
| Change of partial carbon dioxide pressure (PaCO2) | Duration of time and amount that the carbon dioxide Tension values are outside the target range of 40 to 55 mmHg | 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment | 
| Relationship between tidal volume high frequency (Vthf) set and Vthf observed | difference between mean Vthf set and mean 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 | this outcome will be evaluated during periods when no changes to ventilator settings are made. During the first 48 hours of treatment with the investigational device, ventilator settings, VThf and DCO2 will be downloaded from the ventilator's memory along with Ventilator settings for subsequent analysis. | first 48 hours of HFOV treatment | 
| Freedom from Bronchopulmonary Dysplasia (BPD) | Need for any oxygen or positive airway pressure | 36 week's corrected age | 
| Length and Type of Respiratory Support | invasive ventilator support, supplemental oxygen, positive pressure support | participants will be followed for the duration of hospital stay, an expected average of 14 weeks | 
| Neonatal survival | survival with and without the need for supplemental oxygen | participants will be followed for the duration of hospital stay, an expected average of 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Frequency Oscillatory Ventilation, Infant, Very Low Birth Weight, Periventricular Leukomalacia, Intraventricular Hemorrhage, multi-center study