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Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

Primary Purpose

Neonatal Respiratory Distress

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Infasurf Aero

About this trial

This is an expanded access trial for Neonatal Respiratory Distress focused on measuring Infasurf, Surfactant, RDS, Respiratory Distress Syndrome, Aerosolized, Nebulized, Inhaled, Pre-term, Premature

Eligibility Criteria

undefined - 42 Weeks (Child)All Sexes

Inclusion Criteria:

Two cohorts with different entry criteria are included. In cohort 1 are patients with a diagnosis of early RDS who are not intubated and have not received a liquid surfactant instillation. In cohort 2 are patients who received liquid surfactant in the first hour of life, have been extubated and whose RDS is worsening.

Cohort 1 Inclusion Criteria

NICU patient, <12 hours of age.
Clinical diagnosis of RDS, with or without chest X-ray data.
Inspired oxygen ≤40% to maintain adequate oxygen saturation.
Not intubated
Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.

Cohort 2 Inclusion Criteria

NICU patient, <24 hours of age who received liquid surfactant at ≤ 1 hour of age and was extubated.
Clinical diagnosis of RDS, with or without chest X-ray data.
Inspired oxygen ≤40% to maintain adequate oxygen saturation.
Not intubated
Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.

Exclusion Criteria:

1) Requires >40% inspired oxygen to maintain acceptable oxygenation 2) Requires endotracheal intubation. 3) A co-existing medical condition that makes aerosol administration contraindicated in the judgment of the attending physician.

Sites / Locations

University of Mississippi Medical Center
Sisters of Charity Hospital
Pitt County Memorial Hospital
Jackson-Madison County General Hospital
Utah Valley Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT03582930

First Posted

June 27, 2018

Last Updated

October 27, 2022

Sponsor

ONY

1. Study Identification

Unique Protocol Identification Number

NCT03582930

Brief Title

Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

Official Title

Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

Study Type

Expanded Access

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ONY

4. Oversight

5. Study Description

Brief Summary

Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Endotracheal intubations have undesirable adverse effects on fragile premature infants. Instilling surfactant as a liquid suspension into the lung is associated with adverse events due to interruption of breathing in patients who already have respiratory insufficiency. This treatment protocol is expanded access that offers the opportunity for patients to receive aerosolized Infasurf prior to FDA acting on ONY Biotech's application for approval for commercial marketing of aerosolized Infasurf.

Detailed Description

This Treatment Protocol will offer patients access to aerosolized Infasurf therapy at the time RDS is diagnosed if a patient is <12 hours of age and has not previously received liquid surfactant, or is <24 hours of age, and received liquid surfactant in the first hour after birth, was extubated and RDS is worsening. Parents must give informed consent. Up to 2 repeat doses of aerosolized Infasurf can be administered. Aerosolized Infasurf must be administered as described in the protocol. Adverse events at administration (if any) and all serious adverse events related or possibly related the aerosolized Infasurf therapy will be extracted from the medical record and reported to the sponsor, ONY Biotech. A copy of the discharge summary of patients will be collected by the sponsor using HIPAA compliant methodology for generation of a data set that will characterize adverse events and other efficacy and safety data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Respiratory Distress

Keywords

Infasurf, Surfactant, RDS, Respiratory Distress Syndrome, Aerosolized, Nebulized, Inhaled, Pre-term, Premature

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Combination Product

Intervention Name(s)

Infasurf Aero

Intervention Description

Aerosolization of Infasurf administered to premature babies suffering from RDS. Successful administration of Infasurf by aerosolization will provide two important benefits for patients. (1) endotracheal intubation may be able to be avoided in some patients, and (2) the adverse events at instillation due to filling the airway with liquid and interrupting breathing may be diminished or abolished.

10. Eligibility

Sex

All

Maximum Age & Unit of Time

42 Weeks

Eligibility Criteria

Inclusion Criteria: Two cohorts with different entry criteria are included. In cohort 1 are patients with a diagnosis of early RDS who are not intubated and have not received a liquid surfactant instillation. In cohort 2 are patients who received liquid surfactant in the first hour of life, have been extubated and whose RDS is worsening. Cohort 1 Inclusion Criteria NICU patient, <12 hours of age. Clinical diagnosis of RDS, with or without chest X-ray data. Inspired oxygen ≤40% to maintain adequate oxygen saturation. Not intubated Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation. Cohort 2 Inclusion Criteria NICU patient, <24 hours of age who received liquid surfactant at ≤ 1 hour of age and was extubated. Clinical diagnosis of RDS, with or without chest X-ray data. Inspired oxygen ≤40% to maintain adequate oxygen saturation. Not intubated Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation. Exclusion Criteria: 1) Requires >40% inspired oxygen to maintain acceptable oxygenation 2) Requires endotracheal intubation. 3) A co-existing medical condition that makes aerosol administration contraindicated in the judgment of the attending physician.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Corey Commaroto, RRT

Phone

7164283124

Ext

124

ccommaroto@onybiotech.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dan Swartz, PhD

Info@onybiotech.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jim Cummings, MD

Organizational Affiliation

Albany Medical College

Official's Role

Study Chair

Facility Information:

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heather Williams, RN, Study Coordinator

Phone

601-815-3070

hbarth@umc.edu

First Name & Middle Initial & Last Name & Degree

Mobolaji Famuyide, MD

Facility Name

Sisters of Charity Hospital

City

Buffalo

State/Province

New York

ZIP/Postal Code

14214

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

George Albert, MD

Phone

716-862-1000

First Name & Middle Initial & Last Name & Degree

George Albert, MD

Facility Name

Pitt County Memorial Hospital

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27835

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherry Moseley, RN

moseleysh@ecu.edu

First Name & Middle Initial & Last Name & Degree

Srikanth Ravisankar, MD

Facility Name

Jackson-Madison County General Hospital

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38301

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sharon Wadley, BSN

sharon.wadley@wth.org

First Name & Middle Initial & Last Name & Degree

Scott Guthrie, MD

Facility Name

Utah Valley Hospital

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tonya Edvalson, BS,CCRP

Phone

801-507-7036

tonya.edvalson@imail.org

First Name & Middle Initial & Last Name & Degree

Steven Minton, MD

12. IPD Sharing Statement

Learn more about this trial

Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

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