Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-24
SponsorAerogen Pharma Limited
About this trial
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.
Eligibility criteria
Qualifiers
Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
Gestational age at birth of 26 through 33 weeks PMA
Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
Birth weight ≤ 2000 grams
Disqualifiers
On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization
Prior instillation of surfactant
Premature rupture of membranes (PROM) occurring > 14 days before birth
Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
Trial design
Treatments tested in this trial
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
- Control
Treatment groups
520 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov