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

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ONY
• Collaborator: AHRM
• Treatments: Calfactant

Criteria

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.