A pilot study in premature infants who are born at less than 29 weeks to determine if surfactant given by aerosol is safe and well-tolerated.

Phase 2

Completed

• Conditions: Respiratory Distress Syndrome; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12617001458325
• Lead Sponsor: CPR Pharma Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-16
• Study Completion: 2018-10-24
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Preterm infants born at 26 0/7 to 29 6/7 weeks gestational age, with weight appropriate for age, who are on nCPAP, and a FiO2 less than 0.30.

Exclusion Criteria

Preterm infants who required mechanical ventilation and prior instillation of surfactant; significant congenital anomaly; other diseases that might interfere with cardiopulmonary functions; known or suspected chromosomal abnormality; concomitant treatment with inhaled nitric oxide.

Study & Design

• Study Type: Interventional
• Study Design: Not specified