Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

Inclusion Criteria

• •Two cohorts with different entry criteria are included. In cohort 1 are patients with a diagnosis of early RDS who are not intubated and have not received a liquid surfactant instillation. In cohort 2 are patients who received liquid surfactant in the first hour of life, have been extubated and whose RDS is worsening.
• •1. NICU patient, \<12 hours of age.
• •2. Clinical diagnosis of RDS, with or without chest X-ray data.
• •3. Inspired oxygen ≤40% to maintain adequate oxygen saturation.
• •4. Not intubated
• •5. Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.
• •1. NICU patient, \<24 hours of age who received liquid surfactant at ≤ 1 hour of age and was extubated.
• •2. Clinical diagnosis of RDS, with or without chest X-ray data.
• •3. Inspired oxygen ≤40% to maintain adequate oxygen saturation.
• •4. Not intubated
• •5. Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.