NCT02445040

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

May 5, 2015

Last Update Submit

September 11, 2019

Conditions

Respiratory Distress Syndrome In Premature Infants

Keywords

High Frequency Oscillatory VentilationInfant, Very Low Birth WeightPeriventricular LeukomalaciaIntraventricular Hemorrhagemulti-center study

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Freedom from study-defined serious adverse events

    during Treatment Phase (up to 14 days)

  • Device failure rate

    during Treatment Phase (up to 14 days)

  • Neurodevelopment assessment

    22 - 24 months corrected age

  • Change of partial carbon dioxide pressure (PaCO2)

    2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment

  • Relationship between tidal volume high frequency (Vthf) set and Vthf observed

    2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment

  • +4 more secondary outcomes

Study Arms (1)

Babylog VN500 in HFOV mode

EXPERIMENTAL

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

Interventions

Babylog VN500 in HFOV ModeDEVICE

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

Babylog VN500 in HFOV mode

Eligibility Criteria

Age23 Weeks - 30 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational Age between 23 to 30 weeks; within first 4 days of life
  • very low birth weight between 400 g and 1200 g, inclusive
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

St. Paul Children's Hospital

Saint Paul, Minnesota, 55102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28402, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Health Science Center

Salt Lake City, Utah, 84158-1289, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature InfantsLeukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEncephalomalaciaVascular DiseasesCardiovascular DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Martin Keszler, MD

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 15, 2015

Study Start

July 1, 2015

Primary Completion

May 8, 2018

Study Completion

September 1, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(14)