Conditions: Respiratory Distress Syndrome
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 80
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP arm 2: 50 mg TPL/kg: Lucinactant for inhalation with nCPAP arm 3: 75 mg TPL/kg: Lucinactant for inhalation with nCPAP arm 4: 100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. arm 5: 150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. arm 6: nCPAP therapy alone

Interventions: intervention 1: Lucinactant for Inhalation intervention 2: nCPAP alone
Intervention descriptions: intervention 1: Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) intervention 2: nCPAP therapy

Protocol document: