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

NCT02445040 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2019-09-19

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome In Premature Infants

Interventions

DEVICE

Babylog VN500 in HFOV Mode

Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days

Sponsors & Collaborators

  • Draeger Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Keszler, MD · Women and Infants Hospital of Rhode Island

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-05-08
Completion
2020-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445040 on ClinicalTrials.gov