InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
NCT ID: NCT05960929
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2025-01-01
2026-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The subject's family will remain blinded to treatment assignment throughout.
Study Groups
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Treatment Arm
A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.
Infasurf Aero™
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Control Arm
Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.
Infasurf Aero™
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Interventions
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Infasurf Aero™
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Eligibility Criteria
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Inclusion Criteria
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
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
29 Weeks
36 Weeks
ALL
No
Sponsors
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Avania
INDUSTRY
ONY
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Guthrie, MD
Role: STUDY_CHAIR
Vanderbilt Jackson-Madison, Jackson TN
Dinushan Kaluarachchi, MD
Role: STUDY_CHAIR
Unity Point Meriter, Madison WI
Jim Cummings, MD
Role: STUDY_DIRECTOR
Ony Biotech
Locations
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St. Josephs Hospital and Medical Center
Phoenix, Arizona, United States
Phoenix Children's
Phoenix, Arizona, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
University of Florida -Jacksonville
Jacksonville, Florida, United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Sisters of Charity Hospital
Buffalo, New York, United States
Western TN- Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Utah Valley Hospital
Provo, Utah, United States
Unity Point Meriter
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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George Albert, MD
Role: primary
Other Identifiers
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AERO-05 Protocol
Identifier Type: -
Identifier Source: org_study_id
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