Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Purpose
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Condition
- Respiratory Distress Syndrome
Eligibility
- Eligible Ages
- Between 1 Hour and 24 Hours
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Aerosolized Calfactant |
NICU Patients with a clinical diagnosis of RDS Inspired oxygen ≥21% to maintain adequate oxygen saturation Not Intubated Requiring Nasal continuous positive airway pressure |
|
|
No Intervention Usual Care |
There will be no protocol driven interventions in the usual care group. |
|
More Details
- Status
- Completed
- Sponsor
- ONY
Study Contact
Detailed Description
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.