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Aerosolized Surfactant in Neonatal RDS — AS-02  

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:
Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study

Clinical Trial Summary

Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants. Intratracheal instillation, the only approved means of surfactant delivery, requires endotracheal intubation and mechanical ventilation with their attendant risks. Interventions that decrease need for intubation and mechanical ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are increasingly being used for initial respiratory support in preterm neonates with RDS to improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar recruitment while obviating the risks of intubation and mechanical ventilation. The investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in preterm infants undergoing NIV is safe and feasible and will result in short-term improvement in oxygenation and ventilation. The objective of this proposal is to perform a single-center unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome
Clinical Trial Details
NCT number NCT02294630
Study type Interventional
Source Sood, Beena G., MD, MS
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2014
Completion date July 2020
View Details
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