Clinical trial NCT06776783: Safety and Efficacy of AeroFact in Preterm Infants With Respiratory Distress Syndrome
Official title: A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of AeroFact™ (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Respiratory Distress Syndrome
Pre-term Infants
Keywords: respiratory distress syndrome
surfactant
pre-term infant
Lead sponsor: Aerogen Pharma Limited
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 260
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with AeroFact 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 12 months corrected age.


Eligibility criteria: Inclusion Criteria:

1. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
2. Gestational age at birth of 26 through 31 weeks (260/7 through 316/7 weeks PMA)
3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
4. Birth weight ≤ 2000 grams
5. Post-natal age 1 to 24 hours at randomization
6. On nCPAP or NIV with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
7. FiO2 ≥ 0.23 at randomization
8. nCPAP or mPaw ≥ 6 cm H2O at randomization
9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

Exclusion Criteria:

1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization
2. Prior instillation of surfactant
3. Premature rupture of membranes (PROM) occurring \> 14 days before birth
4. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
5. Pneumothorax
6. Other etiologies of respiratory distress
7. Enrollment in another interventional study with similar efficacy endpoints
8. Apgar score at 5 min of 0-3
9. Prior cardiopulmonary resuscitation (CPR) or epinephrine
10. Base Deficit \> 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
11. Partial pressure of carbon dioxide (PaCO2) \> 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
12. Triplet or higher order multiple birth

Primary outcomes:
measure: Failure Criteria
timeFrame: First 7 days of life
Secondary outcomes:
measure: Instilled Bolus Surfactant
timeFrame: First 72 hours of life
measure: Multiple Bolus Surfactant Doses
timeFrame: First 72 hours of life
measure: Total Number of Bolus Surfactant Doses
timeFrame: First 72 hours of life
Other outcomes:
Locations:
Study officials:
References: