The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
The purpose of this study is to investigate the safety and efficacy of lucinactant for inhalation in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA). Efficacy and safety are based on clinical evaluations. The endpoints specified are similar to those in Protocols 03-CL-1201 and 03-CL-1401 to allow for potential comparison and pooling of results. The objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, compared to nCPAP alone, in preterm neonates with RDS, as assessed by the time to and incidence of respiratory failure and/or death due to RDS over the first 72 hours of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and change in physiologic parameters (FiO2 and PCO2) over the first 72 hours of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
221
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
Nasal CPAP
Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
Time frame: 72 hours
Incidence of Respiratory Failure or Death Due to RDS
Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria
Time frame: 72 hours
Time to nCPAP Failure
Time from birth to nCPAP Failure
Time frame: 72 hours
Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling
The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.
Time frame: 72 hours
Incidence of Respiratory Failure or Death Due to RDS
Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria
Time frame: 28 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Summarizes the number of participants with BPD or alive without BPD
Time frame: 36 weeks post-menstrual age (PMA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Univ. of Arkansas Medical Center
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital of Orange County
Orange, California, United States
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Christiana Care Health System
Newark, Delaware, United States
University of Miami Holtz Children's Hospital
Miami, Florida, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
...and 44 more locations