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

Launched by AEROGEN PHARMA LIMITED · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called AeroFact to see if it helps preterm infants with a condition known as Respiratory Distress Syndrome (RDS). In this trial, babies born between 26 and 31 weeks of pregnancy will be divided into two groups: one group will receive AeroFact along with standard breathing support (nCPAP or NIV), while the other group will receive only the standard breathing support. Researchers will follow the babies until they reach 40 weeks of age or are discharged from the hospital, whichever happens first, and then continue to check on their health for up to a year after their expected due date.

To be eligible for this study, infants must be born at the hospital where the trial is taking place, weigh less than 2000 grams (about 4.4 pounds), and show signs of RDS. They should also be between 1 and 24 hours old at the time of enrollment and require help with breathing. If your baby meets these criteria and is selected for the trial, they will receive either the treatment being studied or the standard care, and their progress will be closely monitored by a team of doctors and nurses. This trial is not yet recruiting participants, but it aims to improve care for preterm infants with breathing difficulties.

Gender

ALL

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