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

Respiratory Distress Syndrome In Premature Infants Clinical Trial

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 Low Birth Weight (VLBW) Neonates

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Respiratory Distress Syndrome In Premature Infants
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn

Clinical Trial Details

NCT number	NCT02445040
Study type	Interventional
Source	Draeger Medical Systems, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 2015
Completion date	September 2020

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