InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

AERO-05 Protocol

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.

2024-07-01

2025-01-01

2025-12-01

Not yet recruiting

Early phase I

220

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 ≤ 36 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 non-invasive respiratory support (i.e., continuous positive airway pressure or non-invasive ventilation) 7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4 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. Culture-positive bacterial sepsis requiring at least 5 days of antibiotic therapy 7. Apgar score \< 3 at 5 minutes of age 8. Umbilical cord gas pH \<7.0 or BD \> 10 9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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™.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "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.\n\nThe subject's family will remain blinded to treatment assignment throughout.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2024-05-02