drugset / Trial / NCT02528318
Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
RandomizedSequentialOpen-labelTreatment
Summary
This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.
Timeline
- Start
- 2015-08
- Primary completion
- 2017-05-31
- Completion
- 2017-08-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lucinactant | Peptide | 50 mg/kg | Other |
| Subject | Lucinactant | Peptide | 75 mg/kg | Other |
| Subject | Lucinactant | Peptide | 100 mg/kg | Other |
| Subject | Lucinactant | Peptide | 150 mg/kg | Other |