A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Intervention: Lucinactant for Inhalation; nCPAP Only
Intervention description: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nasal continuous positive airway pressure (nCPAP).; Nasal continuous positive airway pressure (nCPAP) alone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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).
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: 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.
Enrollment: 12.0
Sex: All
Minimum age: 30 Minutes
Maximum age: 6 Hours
Healthy volunteers: No
Keywords: intubation; surfactant; continuous positive airway pressure; aerosol; respiratory distress syndrome

Summary:

      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).
    

Eligibility criteria:

        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.