Respiratory Distress Syndrome In Premature InfantsNCT02445040
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
A study testing Babylog VN500 in HFOV Mode in people with Respiratory Distress Syndrome In Premature Infants, run by Draeger Medical Systems, Inc. at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 30 weeks
- Conditions the study is for
- Respiratory Distress Syndrome In Premature Infants
- What is being tested?
- Babylog VN500 in HFOV Mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Intermountain Medical Center
Murray, Utah, 84107
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
St. Paul Children's Hospital
Saint Paul, Minnesota, 55102
University of Utah Health Science Center
Salt Lake City, Utah, 84158-1289
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
North Central Baptist Hospital
San Antonio, Texas, 78258
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402
About this study
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
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.
Read the 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.
- Being tested
- Babylog VN500 in HFOV Mode
- Keywords
- High Frequency Oscillatory Ventilation, Infant, Very Low Birth Weight, Periventricular Leukomalacia, Intraventricular Hemorrhage, multi-center study
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babylog VN500 in HFOV ModeDevice
Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Babylog VN500 in HFOV mode | Experimental | Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days. Receives: Device: Babylog VN500 in HFOV Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
Papile's grading on cranial ultrasound
Measured: Day 32 +/- 10 days gestational age
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
Measured: 12 hours after onset of HFOV treatment
Secondary outcomes (9)
Freedom from study-defined serious adverse events
Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport
Measured: during Treatment Phase (up to 14 days)
Device failure rate
malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator
Measured: during Treatment Phase (up to 14 days)
Neurodevelopment assessment
Bayley Scales of Infant and Toddler Development III
Measured: 22 - 24 months corrected age
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
Measured: 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment
Relationship between tidal volume high frequency (Vthf) set and Vthf observed
difference between mean Vthf set and mean Vthf observed
Measured: 2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment
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.
Measured: first 48 hours of HFOV treatment
Freedom from Bronchopulmonary Dysplasia (BPD)
Need for any oxygen or positive airway pressure
Measured: 36 week's corrected age
Length and Type of Respiratory Support
invasive ventilator support, supplemental oxygen, positive pressure support
Measured: participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Neonatal survival
survival with and without the need for supplemental oxygen
Measured: participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJul 2015
- Primary completion8 May 2018
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome In Premature InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Draeger Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Keszler, MD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445040
- Sponsor's protocol ID
- I100738
- Status last verified
- Sep 2019
- First submitted
- 5 May 2015
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02445040
- Acronym / sponsor ID
- I100738
- Keywords
- High Frequency Oscillatory Ventilation, Infant, Very Low Birth Weight, Periventricular Leukomalacia, Intraventricular Hemorrhage, multi-center study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Draeger Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babylog VN500 in HFOV mode | Experimental | Device: Babylog VN500 in HFOV ModeSubjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days. |
Who may qualify
- Ages
- 23 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Babylog VN500 in HFOV ModeTreatment with high frequency oscillatory ventilation with investigational device for up to 14 days | Device | Babylog VN500 in HFOV mode |
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
A-a Gradient as measured by arterial blood gas after onset of Treatment with the Babylog VN500 in HFOV mode
9 secondary outcomes
Freedom from study-defined serious adverse events
Time frame: during Treatment Phase (up to 14 days)
Device failure rate
Time frame: during Treatment Phase (up to 14 days)
Neurodevelopment assessment
Time frame: 22 - 24 months corrected age
Change of partial carbon dioxide pressure (PaCO2)
Time frame: 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment
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
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
Length and Type of Respiratory Support
Time frame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Neonatal survival
Time frame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Keszler, MD principal investigator
Women and Infants Hospital of Rhode Island
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Babylog VN500 in HFOV Mode in people with Respiratory Distress Syndrome In Premature Infants, run by Draeger Medical Systems, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL) (time frame: Day 32 +/- 10 days gestational age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.