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

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ClinicalTrials.gov Identifier: NCT02445040
Recruitment Status : Active, not recruiting
First Posted : May 15, 2015
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Draeger Medical Systems, Inc.

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome In Premature Infants Device: Babylog VN500 in HFOV Mode Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : May 8, 2018
Estimated Study Completion Date : December 2020


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




Primary Outcome Measures :
  1. 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

  2. Alveolar-arterial (A-a) Gradient change [ Time Frame: 12 hours after onset of HFOV treatment ]

Secondary Outcome Measures :
  1. Freedom from study-defined serious adverse events [ Time Frame: during Treatment Phase (up to 14 days) ]
    Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport

  2. Device failure rate [ Time Frame: during Treatment Phase (up to 14 days) ]
    malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator

  3. Neurodevelopment assessment [ Time Frame: 22 - 24 months corrected age ]
    Bayley Scales of Infant and Toddler Development III

  4. Change of partial carbon dioxide pressure (PaCO2) [ Time Frame: 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment ]
    Duration of time and amount that the carbon dioxide Tension values are outside the target range of 40 to 55 mmHg

  5. 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 ]
    difference between mean Vthf set and mean Vthf observed

  6. 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 ]
  7. Freedom from Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 week's corrected age ]
    Need for any oxygen or positive airway pressure

  8. Length and Type of Respiratory Support [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks ]
    invasive ventilator support, supplemental oxygen, positive pressure support

  9. Neonatal survival [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 14 weeks ]
    survival with and without the need for supplemental oxygen



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Ages Eligible for Study:   23 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445040


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

Responsible Party: Draeger Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02445040     History of Changes
Other Study ID Numbers: I100738
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Draeger Medical Systems, Inc.:
High Frequency Oscillatory Ventilation
Infant, Very Low Birth Weight
Periventricular Leukomalacia
Intraventricular Hemorrhage
multi-center study

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases