drugset / Trial / NCT02825953

Does The Surfactant Administration by Aerosolization Effective?

NCT02825953

Unknown 75 enrolled nihat demir
RandomizedParallel-groupSingle-blindTreatment

Summary

The present study was designed to evaluate, in premature babies with RDS breathing spontaneously, the efficacy of combined treatment with nasal continuous positive airway pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to assess the safety of surfactant nebulization in this clinical situation, and to find out whether treatment with aerosolized surfactant would reduce the need for mechanical ventilation. And other aim suggest that aerosolized dates compared with dates of INSURE (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.

Timeline

Start
2016-01
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Poractant alfa Other / unclassified 200 mg/kg Inhaled