Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 477
- Locations
- 22
- Primary Endpoint
- Intubation and Instillation of Liquid Surfactant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 24 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •nasal continuous positive airway pressure (nCPAP).
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Aerosolized Calfactant (Drug)
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
Intervention: Solarys (Device)
Outcomes
Primary Outcomes
Intubation and Instillation of Liquid Surfactant
Time Frame: 72 hours
Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
Secondary Outcomes
- Respiratory Support Requirements(28 days)
- Air Leak(28 days)