search
Back to results

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

Primary Purpose

Respiratory Distress Syndrome In Premature Infants

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Babylog VN500 in HFOV Mode
Sponsored by
Draeger Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome In Premature Infants focused on measuring High Frequency Oscillatory Ventilation, Infant, Very Low Birth Weight, Periventricular Leukomalacia, Intraventricular Hemorrhage, multi-center study

Eligibility Criteria

23 Weeks - 30 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Children's Hospital
  • University of Arkansas for Medical Sciences
  • Sharp Mary Birch Hospital for Women and Newborns
  • University of Iowa Hospitals and Clinics
  • Children's Hospitals and Clinics of Minnesota
  • St. Paul Children's Hospital
  • University of Mississippi Medical Center
  • New Hanover Regional Medical Center
  • Women & Infants Hospital of Rhode Island
  • Medical University of South Carolina
  • University of Texas Health Science Center at San Antonio
  • North Central Baptist Hospital
  • Intermountain Medical Center
  • University of Utah Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Babylog VN500 in HFOV mode

Arm Description

Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days.

Outcomes

Primary Outcome Measures

Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
Papile's grading on cranial ultrasound
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

Secondary Outcome Measures

Freedom from study-defined serious adverse events
Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport
Device failure rate
malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator
Neurodevelopment assessment
Bayley Scales of Infant and Toddler Development III
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
Relationship between tidal volume high frequency (Vthf) set and Vthf observed
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
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.
Freedom from Bronchopulmonary Dysplasia (BPD)
Need for any oxygen or positive airway pressure
Length and Type of Respiratory Support
invasive ventilator support, supplemental oxygen, positive pressure support
Neonatal survival
survival with and without the need for supplemental oxygen

Full Information

First Posted
May 5, 2015
Last Updated
September 11, 2019
Sponsor
Draeger Medical Systems, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02445040
Brief Title
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Draeger Medical Systems, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome In Premature Infants
Keywords
High Frequency Oscillatory Ventilation, Infant, Very Low Birth Weight, Periventricular Leukomalacia, Intraventricular Hemorrhage, multi-center study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Babylog VN500 in HFOV mode
Arm Type
Experimental
Arm Description
Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days.
Intervention Type
Device
Intervention Name(s)
Babylog VN500 in HFOV Mode
Intervention Description
Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days
Primary Outcome Measure Information:
Title
Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
Description
Papile's grading on cranial ultrasound
Time Frame
Day 32 +/- 10 days gestational age
Title
Alveolar-arterial (A-a) Gradient change
Description
A-a Gradient as measured by arterial blood gas after onset of Treatment with the Babylog VN500 in HFOV mode
Time Frame
12 hours after onset of HFOV treatment
Secondary Outcome Measure Information:
Title
Freedom from study-defined serious adverse events
Description
Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport
Time Frame
during Treatment Phase (up to 14 days)
Title
Device failure rate
Description
malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator
Time Frame
during Treatment Phase (up to 14 days)
Title
Neurodevelopment assessment
Description
Bayley Scales of Infant and Toddler Development III
Time Frame
22 - 24 months corrected age
Title
Change of partial carbon dioxide pressure (PaCO2)
Description
Duration of time and amount that the carbon dioxide Tension values are outside the target range of 40 to 55 mmHg
Time Frame
2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment
Title
Relationship between tidal volume high frequency (Vthf) set and Vthf observed
Description
difference between mean Vthf set and mean Vthf observed
Time Frame
2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment
Title
Stability of Vthf observed and carbon dioxide diffusion (DCO2) coefficient monitoring during high frequency oscillation over time
Description
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.
Time Frame
first 48 hours of HFOV treatment
Title
Freedom from Bronchopulmonary Dysplasia (BPD)
Description
Need for any oxygen or positive airway pressure
Time Frame
36 week's corrected age
Title
Length and Type of Respiratory Support
Description
invasive ventilator support, supplemental oxygen, positive pressure support
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Title
Neonatal survival
Description
survival with and without the need for supplemental oxygen
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Keszler, MD
Organizational Affiliation
Women and Infants Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. Paul Children's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
North Central Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Health Science Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84158-1289
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs