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



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:6/17/2018
Start Date:July 2015
End Date:December 2020

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
14
sites
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Sherry Courtney, MD
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Mobolaji Famuyide, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Sherry Courtney, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Steven R. Seidner, MD
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: James Kiger, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Jonathan Klein, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Principal Investigator: Andrea Lampland, MD
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Bradley Yoder, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
?
mi
from
Murray, UT
Click here to add this to my saved trials
101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Principal Investigator: Martin Keszler, MD
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
?
mi
from
Providence, RI
Click here to add this to my saved trials
345 Smith Avenue North
Saint Paul, Minnesota 55102
Principal Investigator: Andrea Lampland, MD
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Principal Investigator: Bradley Yoder, MD
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78258
Principal Investigator: Jaclyn LeVan, DO
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
Principal Investigator: David Kaegi, MD
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
Principal Investigator: Fernando Moya, MD
?
mi
from
Wilmington, NC
Click here to add this to my saved trials