Clinical trial NCT02445040: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome In Premature Infants
Keywords: High Frequency Oscillatory Ventilation
Infant, Very Low Birth Weight
Periventricular Leukomalacia
Intraventricular Hemorrhage
multi-center study
Lead sponsor: Draeger Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 225
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
timeFrame: Day 32 +/- 10 days gestational age
measure: Alveolar-arterial (A-a) Gradient change
timeFrame: 12 hours after onset of HFOV treatment
Secondary outcomes:
measure: Freedom from study-defined serious adverse events
timeFrame: during Treatment Phase (up to 14 days)
measure: Device failure rate
timeFrame: during Treatment Phase (up to 14 days)
measure: Neurodevelopment assessment
timeFrame: 22 - 24 months corrected age
measure: Change of partial carbon dioxide pressure (PaCO2)
timeFrame: 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment
measure: Relationship between tidal volume high frequency (Vthf) set and Vthf observed
timeFrame: 2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment
measure: Stability of Vthf observed and carbon dioxide diffusion (DCO2) coefficient monitoring during high frequency oscillation over time
timeFrame: first 48 hours of HFOV treatment
measure: Freedom from Bronchopulmonary Dysplasia (BPD)
timeFrame: 36 week's corrected age
measure: Length and Type of Respiratory Support
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks
measure: Neonatal survival
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: St. Paul Children's Hospital
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Martin Keszler, MD
role: PRINCIPAL_INVESTIGATOR
References: