Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Treatment will not be masked. The study objective is to document that aerosolized Infasurf is
superior to "usual care" and provides for some patients effective surfactant therapy with
less need for endotracheal intubation and instillation of a surfactant suspension into the
airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth
who develop RDS in the first hours of life and (b) patients who received instillation of
surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.

Inclusion Criteria:

RDS Patients

1. NICU patient, ≥1hour of age and <24 hours of age.

2. Clinical diagnosis of RDS, with or without chest X-ray data.

3. Inspired oxygen ≥21% to maintain adequate oxygen saturation.

4. Not intubated

5. Requiring:

1. nasal continuous positive airway pressure (nCPAP).

Exclusion Criteria:

1. Congenital anomaly limiting care options or requiring early surgery.

2. Cardiopulmonary decompensation.

1. hypotension with metabolic acidosis (base excess < -10 meq/l).

2. Oxygen saturations < 88% at start of aerosolization.

3. PaCO2 ≥ 60 mmHg at start of aerosolization.

3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.

4. Acute hypoxic encephalopathy with or without seizures.