The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth. Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
261
Intubation/Cannulation and Instilled Surfactant
Number of patients who require intubation/cannulation with bolus surfactant instillation
Time frame: First 7 days of life
Time to First Intubation/Cannulation and Bolus Surfactant Instillation
Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life
Time frame: First 7 days of life
Proportion of Infants Who Received Multiple Doses of Bolus Surfactant
Time frame: First 7 days of life
Number of Days on Invasive Mechanical Ventilation
Total number of days each participant required support with invasive mechanical ventilation
Time frame: Assessed daily from birth to 40 weeks post-menstrual age or discharge
Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)
Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA
Time frame: Birth to 36 weeks post-menstrual age
Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)
Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA
Time frame: Birth to 40 weeks post-menstrual age
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