Back to resultsInfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (Aero-05)
Primary Purpose
Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Infasurf Aero™
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome (Neonatal) focused on measuring Infasurf, Calfactant, Inhalation, Nebulization, Preterm, InfasurfAero, Respiratory Distress Syndrome, Neonatal, NICU, CPAP, Intubation, Aerosol, CPAP Failure
Eligibility Criteria
Inclusion Criteria: Inclusion criteria include ALL of the following: Written informed consent obtained by parent or legal representative prior to or after birth Gestational age at birth ≥ 29 0/7 AND ≤ 36 6/7 weeks Birthweight ≥ 1,000 AND ≤ 3,500 grams Age ≥ 1 hour AND ≤ 6 hours Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation Require non-invasive respiratory support (i.e., continuous positive airway pressure or non-invasive ventilation) Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4 Exclusion Criteria: Exclusion criteria are ANY of the following: Surfactant administration prior to randomization Mechanical ventilation prior to randomization Major congenital anomaly (suspected or confirmed) Abnormality of the airway (suspected or confirmed) Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) Culture-positive bacterial sepsis requiring at least 5 days of antibiotic therapy Apgar score < 3 at 5 minutes of age Umbilical cord gas pH <7.0 or BD > 10 Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Sites / Locations
- Sharp Mary Birch Hospital for Women & Newborns
- Johns Hopkins All Children's Hospital
- Sisters of Charity Hospital
- Jackson-Madison County General Hospital
- Utah Valley Hospital
- Unity Point Meriter
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment Arm
Control Arm
Arm Description
A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.
Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.
Outcomes
Primary Outcome Measures
CPAP failure and or death
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) >2.5 on two consecutive assessments at least 30 minutes apart, or an RSS > 2.4 and one or more of the following:
(i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support.
(ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation).
(iii) Respiratory acidosis (pCO2 > 65 with a pH < 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.
Secondary Outcome Measures
Chronic lung disease and or death
Chronic lung disease is defined as altitude adjusted oxygen requirement at 36 weeks post menstrual age.
Incidence of MV
Incidence of Mechanical Ventilation
Duration of MV
length of time of Mechanical Ventilation
Incidence of intubation
Any occurrence of tracheal intubation
Incidence of invasive surfactant replacement therapy
any occurrence of liquid surfactant administration via and endotracheal tube
Duration of non-invasive support
Length of time of respiratory support other than Intubation
Duration of supplemental oxygen
Length of time any oxygen is administered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05960929
Brief Title
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
Acronym
Aero-05
Official Title
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONY
Collaborators
Avania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Detailed Description
This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.
Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
Keywords
Infasurf, Calfactant, Inhalation, Nebulization, Preterm, InfasurfAero, Respiratory Distress Syndrome, Neonatal, NICU, CPAP, Intubation, Aerosol, CPAP Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All study procedures will be performed behind a portable screen or curtain, or in a separate procedure room so that non-study personnel (including the primary care team) will be unaware of the subject's assigned study arm. Study personnel involved in the study procedure will not be masked. All other study personnel including the investigator and the outcomes accessor will be masked throughout the duration of the study.
The subject's family will remain blinded to treatment assignment throughout.
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.
Intervention Type
Combination Product
Intervention Name(s)
Infasurf Aero™
Intervention Description
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Primary Outcome Measure Information:
Title
CPAP failure and or death
Description
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) >2.5 on two consecutive assessments at least 30 minutes apart, or an RSS > 2.4 and one or more of the following:
(i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support.
(ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation).
(iii) Respiratory acidosis (pCO2 > 65 with a pH < 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.
Time Frame
Within 1st week of age
Secondary Outcome Measure Information:
Title
Chronic lung disease and or death
Description
Chronic lung disease is defined as altitude adjusted oxygen requirement at 36 weeks post menstrual age.
Time Frame
36 weeks post menstrual age (PMA).
Title
Incidence of MV
Description
Incidence of Mechanical Ventilation
Time Frame
36 weeks PMA
Title
Duration of MV
Description
length of time of Mechanical Ventilation
Time Frame
36 weeks PMA
Title
Incidence of intubation
Description
Any occurrence of tracheal intubation
Time Frame
36 weeks PMA
Title
Incidence of invasive surfactant replacement therapy
Description
any occurrence of liquid surfactant administration via and endotracheal tube
Time Frame
72 hours post birth
Title
Duration of non-invasive support
Description
Length of time of respiratory support other than Intubation
Time Frame
36 weeks PMA
Title
Duration of supplemental oxygen
Description
Length of time any oxygen is administered.
Time Frame
36 weeks PMA
Other Pre-specified Outcome Measures:
Title
Adverse events during surfactant administration.
Description
Incidence of bradycardia and desaturation during surfactant administration.
Time Frame
Birth to 72 hours of age.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria include ALL of the following:
Written informed consent obtained by parent or legal representative prior to or after birth
Gestational age at birth ≥ 29 0/7 AND ≤ 36 6/7 weeks
Birthweight ≥ 1,000 AND ≤ 3,500 grams
Age ≥ 1 hour AND ≤ 6 hours
Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
Require non-invasive respiratory support (i.e., continuous positive airway pressure or non-invasive ventilation)
Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
Exclusion Criteria:
Exclusion criteria are ANY of the following:
Surfactant administration prior to randomization
Mechanical ventilation prior to randomization
Major congenital anomaly (suspected or confirmed)
Abnormality of the airway (suspected or confirmed)
Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
Culture-positive bacterial sepsis requiring at least 5 days of antibiotic therapy
Apgar score < 3 at 5 minutes of age
Umbilical cord gas pH <7.0 or BD > 10
Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corey Commaroto, RRT
Phone
7163614659
Email
ccommaroto@onybiotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Swartz, PhD
Phone
716428-3132
Email
dswartz@onybiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Guthrie, MD
Organizational Affiliation
Vanderbilt Jackson-Madison, Jackson TN
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dinushan Kaluarachchi, MD
Organizational Affiliation
Unity Point Meriter, Madison WI
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jim Cummings, MD
Organizational Affiliation
Ony Biotech
Official's Role
Study Director
Facility Information:
Facility Name
Sharp Mary Birch Hospital for Women & Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
First Name & Middle Initial & Last Name & Degree
Prem Fort, MD
Facility Name
Sisters of Charity Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
Jackson-Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Wadley, BSN
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
Facility Name
Unity Point Meriter
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
First Name & Middle Initial & Last Name & Degree
Dinushuan Kaluarachchi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
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