Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Intervention: Lucinactant for Inhalation; nCPAP alone
Intervention description: Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product); nCPAP therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential escalating dosing groups, each group contained an active and control arm of equal size.
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 29 Weeks
Maximum age: 34 Weeks
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of aerosolized
      surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses
      to preterm neonates 29 to 34 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:

          -  Informed consent from a legally authorized representative

          -  Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)

          -  Successful implementation of controlled nCPAP within 90 minutes after birth

          -  Spontaneous breathing

          -  Chest radiograph consistent with RDS

          -  Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen
             saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

        Exclusion Criteria:

          -  Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth

          -  Recurrent episodes of apnea occurring after the initial newborn resuscitation period
             (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using
             inflating pressures above the set CPAP pressure administered manually or mechanically
             through any patient interface

          -  A 5 minute Apgar score < 5

          -  Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP,
             diagnosed antenatally or immediately after birth

          -  Other diseases or conditions potentially interfering with cardiopulmonary function
             (eg, hydrops fetalis or congenital infection such as TORCH)

          -  Known or suspected chromosomal abnormality or syndrome

          -  Prolong rupture of membranes (PROM) > 2 weeks

          -  Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic
             support and/or presumed clinical sepsis

          -  Need for endotracheal intubation and mechanical ventilation

          -  Has been administered: another investigational agent or exposure to an investigational
             medical device, any other surfactant agent, steroid treatment after birth