NCT02294630

Aerosolized Surfactant in Neonatal RDS

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Sood, Beena G., MD, MS · Individual
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
DRUG	Surfactant	Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-07-01
• Completion: 2020-07-01
• First posted: 2014-11-19
• Last updated: 2021-08-25
• Results posted: 2021-08-25

Locations

1 site across 1 country: United States