The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: Lucinactant delivered via investigational delivery device; nCPAP
Intervention description: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product); Nasal CPAP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 26 Weeks
Maximum age: 32 Weeks
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent form (ICF) from legally authorized representative

          2. 26 0/7 to 32 6/7 completed weeks gestation PMA

          3. Successful implementation of non-invasive support or ventilation within 90 minutes
             after birth

          4. Spontaneous breathing

          5. Chest radiograph consistent with RDS

          6. 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:

          1. A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5
             minutes of birth

          2. Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered
             manually or mechanically through any patient interface

          3. A 5 minute Apgar score < 5

          4. Major congenital malformation(s) or craniofacial abnormalities that preclude the use
             of nCPAP, diagnosed antenatally or immediately after birth

          5. 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)

          6. A known or suspected chromosomal abnormality or syndrome

          7. Premature rupture of membranes (PROM) > 3 weeks

          8. Hemodynamic instability requiring vasopressors or steroids for hemodynamic support
             and/or presumed clinical sepsis

          9. A need for intubation and/or mechanical ventilation at any time before enrollment into
             the study

         10. 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)

         11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous
             emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the
             baseline chest radiograph