Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02636868 | The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age | PHASE2 | COMPLETED | 221 | — | — | Dec 1, 2015 | Aug 6, 2019 | Apr 23, 2021 | 54 | United States, Canada +6 |
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
| Arm | Type | Description |
|---|---|---|
| Aerosolized lucinactant (low dose) | EXPERIMENTAL | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
| Aerosolized lucinactant (high dose) | EXPERIMENTAL | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
| nasal CPAP | ACTIVE_COMPARATOR | nCPAP alone |
| Name | Type | Description |
|---|---|---|
| Lucinactant delivered via investigational delivery device | DRUG | Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) |
| nCPAP | DRUG | Nasal CPAP |
Inclusion Criteria: 1. Signed informed consent form (ICF) from legally authorized representative 2. 26 0/7 to 32 6/7 completed weeks gestation PMA 3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth 4. Spontaneous breathing 5. Chest radiograph consisten...