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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02445040
• Other study ID #: I100738
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2020

Study information

• Verified date: September 2019
• Source: Draeger Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: September 2020
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 30 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Babylog VN500 in HFOV Mode
Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	St. Paul Children's Hospital	Saint Paul	Minnesota
United States	University of Utah Health Science Center	Salt Lake City	Utah
United States	North Central Baptist Hospital	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Draeger Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)	Papile's grading on cranial ultrasound	Day 32 +/- 10 days gestational age
Primary	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	12 hours after onset of HFOV treatment
Secondary	Freedom from study-defined serious adverse events	Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport	during Treatment Phase (up to 14 days)
Secondary	Device failure rate	malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator	during Treatment Phase (up to 14 days)
Secondary	Neurodevelopment assessment	Bayley Scales of Infant and Toddler Development III	22 - 24 months corrected age
Secondary	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	2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment
Secondary	Relationship between tidal volume high frequency (Vthf) set and Vthf observed	difference between mean Vthf set and mean Vthf observed	2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment
Secondary	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.	first 48 hours of HFOV treatment
Secondary	Freedom from Bronchopulmonary Dysplasia (BPD)	Need for any oxygen or positive airway pressure	36 week's corrected age
Secondary	Length and Type of Respiratory Support	invasive ventilator support, supplemental oxygen, positive pressure support	participants will be followed for the duration of hospital stay, an expected average of 14 weeks
Secondary	Neonatal survival	survival with and without the need for supplemental oxygen	participants will be followed for the duration of hospital stay, an expected average of 14 weeks