The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

Phase 2

Completed

Interventions: Drug: Lucinactant delivered via investigational delivery device
Drug: nCPAP

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent form (ICF) from legally authorized representative
26 0/7 to 32 6/7 completed weeks gestation PMA
Successful implementation of non-invasive support or ventilation within 90 minutes after birth
Spontaneous breathing
Chest radiograph consistent with RDS
Within the first 20 hours after birth requires an nCPAP of 5 to 7 centimeters water (cmH2O) with a fraction of inspired oxygen (FiO2) of ≥ 0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain oxygen by pulse oximetry (SpO2) of 90% to 95%. Transient (<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement.

Exclusion Criteria

A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth
Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
A 5 minute Apgar score < 5
Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)
A known or suspected chromosomal abnormality or syndrome
Premature rupture of membranes (PROM) > 3 weeks
Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
A need for intubation and/or mechanical ventilation at any time before enrollment into the study
The administration (or plan for administration) of any the following:
- Another investigational agent or investigational medical device
- Any other surfactant agent
- Systemic corticosteroids (other than antenatal steroids already received)
Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph

Arm && Interventions

Group	Intervention	Description
Aerosolized lucinactant (low dose)	Lucinactant delivered via investigational delivery device	Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Aerosolized lucinactant (low dose)	nCPAP	Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Aerosolized lucinactant (high dose)	Lucinactant delivered via investigational delivery device	Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Aerosolized lucinactant (high dose)	nCPAP	Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
nasal CPAP	nCPAP	nCPAP alone

Primary Outcome Measures

Name	Time	Method
Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)	72 hours	Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure

Secondary Outcome Measures

Name	Time	Method
Incidence of Respiratory Failure or Death Due to RDS	28 days	Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria
Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling	72 hours	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.
Number of Participants With Bronchopulmonary Dysplasia (BPD)	36 weeks post-menstrual age (PMA)	Summarizes the number of participants with BPD or alive without BPD
Time to nCPAP Failure	72 hours	Time from birth to nCPAP Failure

Locations (54): 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
Scroll for more (44 remaining)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States