A Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome
Overview
- Phase
- Phase 2
- Intervention
- nCPAP
- Conditions
- Respiratory Distress Syndrome in Premature Infant
- Sponsor
- Aerogen Pharma Limited
- Enrollment
- 261
- Locations
- 41
- Primary Endpoint
- Intubation/Cannulation and Instilled Surfactant
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
- •26 0/7 to 30 6/7 weeks of gestational age
- •Weight \<2.0 Kg
- •Respiratory Severity Score (RSS) 1.4-2.0
Exclusion Criteria
- •Apgar score less than or equal to 5 at five minutes after birth
- •Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
- •Premature rupture of membranes (PROM) \> 14 days
- •Need for intubation and/or mechanical ventilation prior to enrollment
- •Active pneumothorax requiring chest tube
- •Significant congenital anomaly, chromosomal abnormality
- •Concomitant treatments with inhaled nitric oxide
Arms & Interventions
nCPAP alone
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
Intervention: nCPAP
Drug: Low Dose AeroFact
AeroFact-low dose SF-RI 1
Intervention: AeroFact
Drug: High Dose AeroFact
AeroFact-high dose SF-RI 1
Intervention: AeroFact
Outcomes
Primary Outcomes
Intubation/Cannulation and Instilled Surfactant
Time Frame: First 7 days of life
Number of patients who require intubation/cannulation with bolus surfactant instillation
Secondary Outcomes
- Time to First Intubation/Cannulation and Bolus Surfactant Instillation(First 7 days of life)
- Proportion of Infants Who Received Multiple Doses of Bolus Surfactant(First 7 days of life)
- Number of Days on Invasive Mechanical Ventilation(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)(Birth to 36 weeks post-menstrual age)
- Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)(Birth to 40 weeks post-menstrual age)