Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 29 to 34 Weeks PMA: Dose Escalation and Study Extension

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.

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