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

NCT ID: NCT02445040

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2020-09-30

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.

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.

Conditions

Respiratory Distress Syndrome In Premature Infants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Babylog VN500 in HFOV mode

Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days.

Group Type: EXPERIMENTAL

Babylog VN500 in HFOV Mode

Intervention Type: DEVICE

Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days

Interventions

Babylog VN500 in HFOV Mode

Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 30 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Draeger Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Keszler, MD

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital of Rhode Island

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

St. Paul Children's Hospital

Saint Paul, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

North Central Baptist Hospital

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Health Science Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

I100738

Identifier Type: -

Identifier Source: org_study_id