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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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 Summary: 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.
Sponsor: Draeger Medical Systems, Inc.

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Freedom from study-defined serious adverse events [ Time Frame: during Treatment Phase (up to 14 days) ]
    Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport
  • Device failure rate [ Time Frame: during Treatment Phase (up to 14 days) ]
    malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator
  • Neurodevelopment assessment [ Time Frame: 22 - 24 months corrected age ]
    Bayley Scales of Infant and Toddler Development III
  • Change of partial carbon dioxide pressure (PaCO2) [ Time Frame: 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment ]
    Duration of time and amount that the carbon dioxide Tension values are outside the target range of 40 to 55 mmHg
  • Relationship between tidal volume high frequency (Vthf) set and Vthf observed [ Time Frame: 2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment ]
    difference between mean Vthf set and mean Vthf observed
  • Stability of Vthf observed and carbon dioxide diffusion (DCO2) coefficient monitoring during high frequency oscillation over time [ Time Frame: first 48 hours of HFOV treatment ]
  • Freedom from Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 week's corrected age ]
    Need for any oxygen or positive airway pressure
  • Length and Type of Respiratory Support [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks ]
    invasive ventilator support, supplemental oxygen, positive pressure support
  • Neonatal survival [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks ]
    survival with and without the need for supplemental oxygen


Original Secondary Outcome: Same as current

Information By: Draeger Medical Systems, Inc.

Dates:
Date Received: May 5, 2015
Date Started: July 2015
Date Completion: July 2019
Last Updated: May 12, 2017
Last Verified: May 2017