NCT02445040

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Draeger Medical Systems, Inc. · Industry
• Sex: All
• Age: 23 Weeks – 30 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome In Premature Infants

Interventions

Type	Name	Description
DEVICE	Babylog VN500 in HFOV Mode	Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-05-08
• Completion: 2020-09-01
• First posted: 2015-05-15
• Last updated: 2019-09-19

Locations

14 sites across 1 country: United States