Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Device: Solarys
- Registration Number
- NCT03058666
- Lead Sponsor
- ONY
- Brief Summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 477
RDS Patients
-
NICU patient, ≥1hour of age and <24 hours of age.
-
Clinical diagnosis of RDS, with or without chest X-ray data.
-
Inspired oxygen ≥21% to maintain adequate oxygen saturation.
-
Not intubated
-
Requiring:
- nasal continuous positive airway pressure (nCPAP).
-
Congenital anomaly limiting care options or requiring early surgery.
-
Cardiopulmonary decompensation.
- hypotension with metabolic acidosis (base excess < -10 meq/l).
- Oxygen saturations < 88% at start of aerosolization.
- PaCO2 ≥ 60 mmHg at start of aerosolization.
-
Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
-
Acute hypoxic encephalopathy with or without seizures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerosolized Calfactant Solarys 1. NICU Patients with a clinical diagnosis of RDS 2. Inspired oxygen ≥21% to maintain adequate oxygen saturation 3. Not Intubated 4. Requiring Nasal continuous positive airway pressure Aerosolized Calfactant Aerosolized Calfactant 1. NICU Patients with a clinical diagnosis of RDS 2. Inspired oxygen ≥21% to maintain adequate oxygen saturation 3. Not Intubated 4. Requiring Nasal continuous positive airway pressure
- Primary Outcome Measures
Name Time Method Intubation and Instillation of Liquid Surfactant 72 hours Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
- Secondary Outcome Measures
Name Time Method Respiratory Support Requirements 28 days Difference of Respiratory support at 28 days
Air Leak 28 days Percent of at risk subjects with air leak at any time
Trial Locations
- Locations (22)
USA Children's & Women's Hospital
🇺🇸Mobile, Alabama, United States
Banner - University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Sharp Mary Birch Hospital for Women & Newborns
🇺🇸San Diego, California, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Adventist Healthcare System, Florida Hospital
🇺🇸Orlando, Florida, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of South Florida, Tampa general
🇺🇸Tampa, Florida, United States
Columbus Regional Hospital
🇺🇸Columbus, Georgia, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Kentucky Children's Hospital, University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Scroll for more (12 remaining)USA Children's & Women's Hospital🇺🇸Mobile, Alabama, United States