Clinical trial NCT05960929: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: 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
Lead sponsor: ONY
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2023-07-27
Enrollment: 220
Sex: ALL
Minimum age (years): 29
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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™.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria include ALL of the following:

1. Written informed consent obtained by parent or legal representative prior to or after birth
2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
4. Age ≥ 1 hour AND ≤ 6 hours
5. 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
6. Require CPAP
7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
8. If subject is \>346/7 weeks' gestation a chest radiograph is required

Exclusion Criteria:

Exclusion criteria are ANY of the following:

1. Surfactant administration prior to randomization
2. Mechanical ventilation prior to randomization
3. Major congenital anomaly (suspected or confirmed)
4. Abnormality of the airway (suspected or confirmed)
5. 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)
6. Apgar score \< 3 at 5 minutes of age
7. Umbilical cord gas pH \<7.0 or BD \> 10
8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Primary outcomes:
measure: CPAP failure and or death
timeFrame: Within 1st week of age
Secondary outcomes:
measure: Chronic lung disease and or death
timeFrame: 36 weeks post menstrual age (PMA).
measure: Incidence of MV
timeFrame: 36 weeks PMA
measure: Duration of MV
timeFrame: 36 weeks PMA
measure: Incidence of intubation
timeFrame: 36 weeks PMA
measure: Incidence of invasive surfactant replacement therapy
timeFrame: 72 hours post birth
measure: Duration of non-invasive support
timeFrame: 36 weeks PMA
measure: Duration of supplemental oxygen
timeFrame: 36 weeks PMA
Other outcomes:
measure: Adverse events during surfactant administration.
timeFrame: Birth to 72 hours of age.
Locations:
city: Phoenix
country: United States
facility: St. Josephs Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's
state: Arizona
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women & Newborns
state: California
city: Jacksonville
country: United States
facility: University of Florida -Jacksonville
state: Florida
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women & Children
state: Hawaii
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Sisters of Charity Hospital
state: New York
city: Jackson
country: United States
facility: Western TN- Jackson-Madison County General Hospital
state: Tennessee
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Madison
country: United States
facility: Unity Point Meriter
state: Wisconsin
Study officials:
affiliation: Vanderbilt Jackson-Madison, Jackson TN
name: Scott Guthrie, MD
role: STUDY_CHAIR
affiliation: Unity Point Meriter, Madison WI
name: Dinushan Kaluarachchi, MD
role: STUDY_CHAIR
affiliation: Ony Biotech
name: Jim Cummings, MD
role: STUDY_DIRECTOR
References: