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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome In Premature Infants
• Intervention / Treatment: Device: Babylog VN500 in HFOV Mode

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 Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
    • Little Rock, Arkansas, United States, 72202
      • University of Arkansas for Medical Sciences
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • St. Paul Children's Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • North Carolina
    • Wilmington, North Carolina, United States, 28402
      • New Hanover Regional Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital of Rhode Island
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78258
      • North Central Baptist Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84158-1289
      • University of Utah Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Babylog VN500 in HFOV mode; Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days.	Device: Babylog VN500 in HFOV Mode; Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Neurodevelopment assessment	Bayley Scales of Infant and Toddler Development III	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	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	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.	first 48 hours of HFOV treatment
Freedom from Bronchopulmonary Dysplasia (BPD)	Need for any oxygen or positive airway pressure	36 week's corrected age
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
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

Collaborators and Investigators

• Sponsor: Draeger Medical Systems, Inc.
• Investigators: Principal Investigator: Martin Keszler, MD, Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): May 8, 2018
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Intraventricular Hemorrhage; Infant, Very Low Birth Weight; Periventricular Leukomalacia; High Frequency Oscillatory Ventilation; multi-center study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: I100738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No