A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation Versus nCPAP Alone in Preterm Neonates 26 to 32 Weeks Gestational Age With RDS

03-CL-1702

This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).

2020-04-18

2021-01-31

2021-03-28

Terminated

Early phase I

12

Inclusion Criteria: * Signed ICF from legally authorized representative. * Gestational age: 26 to 32+6 weeks PMA. * Successful implementation of non-invasive support or ventilation within 30 minutes after birth. * Spontaneous breathing. * Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis. * Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 \> 0.25 to ≤ 0.35 to maintain SpO2 of 90% to 95%. Exclusion Criteria: * A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth. * Recurrent episodes of apnea requiring positive pressure ventilation. * A 5 minute Apgar score \< 5. * Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP. * Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function. * A known or suspected chromosomal abnormality or syndrome. * Premature rupture of membranes \> 3 weeks. * Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis. * A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study. * The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids. * Presence of air leak on the baseline chest radiograph or diagnosed via ultrasound or illumination.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a multinational, multicenter, double-blind (masked), parallel group, randomized, controlled study, in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The first 2 subjects at each site for each cohort will be dosed with open-label active treatment for training purposes. Following the first 2 subjects, preparation and delivery of treatment will be blinded from the study staff. Treatment will be delivered behind a partition and no information about treatment will be given to investigator, parents, or other applicable study staff.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

2023-05-24