Safety and Efficacy of AeroFact in Preterm Infants With Respiratory Distress Syndrome

Phase 3

Not yet recruiting

• Conditions: Respiratory Distress Syndrome; Pre-term Infants

• Registration Number: NCT06776783
• Lead Sponsor: Aerogen Pharma Limited

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Study Start: 2025-04
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Failure Criteria	First 7 days of life	Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV

Secondary Outcome Measures

Name	Time	Method
Instilled Bolus Surfactant	First 72 hours of life	The number (%) of subjects in each group who receive instilled bolus surfactant.
Multiple Bolus Surfactant Doses	First 72 hours of life	The number (%) of subjects in each group who receive multiple doses of bolus surfactant.
Total Number of Bolus Surfactant Doses	First 72 hours of life	The total number of bolus doses of surfactant received per subject in each group.