Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
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
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 26 Weeks
Maximum age: 28 Weeks
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and tolerability of lucinactant for inhalation,
      administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks
      gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent from a legally authorized representative.

          2. Gestational age 26 to 28 completed weeks post menstrual age (PMA).

          3. Successful implementation of controlled nCPAP within 90 minutes after birth.

          4. Spontaneous breathing.

          5. Chest radiograph consistent with RDS.

          6. Within the first 20 hours after birth, have an nCPAP of 5 to 6 cm H2O to maintain
             oxygen saturation measured by pulse oximetry (SpO2) of 88% to 95% with a fraction of
             inspired oxygen (FiO2) of 0.25 to 0.50 that is clinically indicated for at least 30
             minutes. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.50 did not
             reset the 30 minute requirement.

        Exclusion Criteria:

          1. Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth.

          2. 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.

          3. A 5 minute Apgar score < 5.

          4. Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP,
             diagnosed antenatally or immediately after birth.

          5. Other diseases or conditions potentially interfering with cardiopulmonary function
             (eg, hydrops fetalis or congenital infection such as TORCH).

          6. Known or suspected chromosomal abnormality or syndrome.

          7. Premature rupture of membranes (PROM) > 2 weeks.

          8. Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic
             support and/or presumed clinical sepsis.

          9. Need for endotracheal intubation and mechanical ventilation.

         10. Has been administered: another investigational agent or investigational medical
             device, any other surfactant agent, steroid treatment after birth.