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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02074059 | Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates | PHASE2 | COMPLETED | 80 | — | — | Feb 1, 2014 | Nov 1, 2015 | Apr 21, 2017 | 11 | United States |
Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone
Oxygen saturation as determined by pulse oximetry
| Arm | Type | Description |
|---|---|---|
| Aerosolized lucinactant (25 mg/kg) | EXPERIMENTAL | 25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP |
| Aerosolized lucinactant (50 mg/kg) | EXPERIMENTAL | 50 mg TPL/kg: Lucinactant for inhalation with nCPAP |
| Aerosolized lucinactant (75 mg/kg) | EXPERIMENTAL | 75 mg TPL/kg: Lucinactant for inhalation with nCPAP |
| Aerosolized lucinactant (100 mg/kg) | EXPERIMENTAL | 100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. |
| Aerosolized lucinactant (150 mg/kg) | EXPERIMENTAL | 150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. |
| nCPAP alone | ACTIVE_COMPARATOR | nCPAP therapy alone |
| Name | Type | Description |
|---|---|---|
| Lucinactant for Inhalation | DRUG | Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) |
| nCPAP alone | DEVICE | nCPAP therapy |
Inclusion Criteria: * Informed consent from a legally authorized representative * Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA) * Successful implementation of controlled nCPAP within 90 minutes after birth * Spontaneous breathing * Chest radiograph consistent w...