drugset / Trial / NCT03235986
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
RandomizedParallel-groupOpen-labelTreatment
Summary
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.
Timeline
- Start
- 2017-08-28
- Primary completion
- 2020-05-05
- Completion
- 2020-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Poractant alfa | Other / unclassified | 200 mg/kg | Inhaled |
| Subject | Poractant alfa | Other / unclassified | 400 mg/kg | Inhaled |