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

Description

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 Start Date

July 2015

Estimated Completion Date

July 2019

Interventions

  • Device: Babylog VN500 in HFOV Mode

Specialties

  • Nursing: Pediatrics,Pulmonology
  • Pediatrics: Neonatology,Pediatric Pulmonology
  • Pulmonology: Peds Pulmonology
  • Physician Assistant: Pediatrics

MeSH Terms

  • Infant, Newborn, Diseases
  • Infant, Premature, Diseases
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Study ID

Draeger Medical Systems, Inc. -- I100738

Status

Unknown

Trial ID

NCT02445040

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

225

Sponsor

Draeger Medical Systems, Inc.

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

Gender

Both

Ages

23 Weeks to 30 Weeks

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Women Infants Hospital of Rhode Island - Providence, Rhode Island 42.6 miles Alyse Laliberte None None
New Hanover Regional Medical Center - Wilmington, North Carolina 674.4 miles Julie Oliver None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Carrie Weiglein Finch None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,050.4 miles Gretchen Cress None None
St Paul Childrens Hospital - St. Paul, Minnesota 1,114.3 miles Cathy Worwa None None
Childrens Hospitals and Clinics of Minnesota - Minneapolis, Minnesota 1,121.3 miles Samantha Zimmerman None None
University of Arkansas for Medical Sciences - Little Rock, Arkansas 1,258.0 miles Betty Proffitt None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,258.0 miles Tiffany Brown None None
Sharp Mary Birch Hospital for Women and Newborns - San Diego, California 2,579.1 miles Melissa Brown None None

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