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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
Combination productSubjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.
Control
Other interventionSubjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.
Treatment groups
520 Participants
are divided into 2 treatment groupsGroup A: Control GroupSham comparator 1 intervention
Group B: APC-0101 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Failure Criteria
Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV
Time frame
First 7 days of lifeSecondary outcomes
1
Instilled Bolus Surfactant
The number (%) of subjects in each group who receive instilled bolus surfactant.
Time frame
First 72 hours of life2
Multiple Bolus Surfactant Doses
The number (%) of subjects in each group who receive multiple doses of bolus surfactant.
Time frame
First 72 hours of life3
Total Number of Bolus Surfactant Doses
The total number of bolus doses of surfactant received per subject in each group.
Time frame
First 72 hours of lifeSponsors and contacts
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Source ClinicalTrials.gov