Phase 3
N=477
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03058666 ↗Enrolled (actual)
477
Serious AEs
5.7%
Results posted
May 2024
Primary outcome: Primary: Intubation and Instillation of Liquid Surfactant — 69; 120 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aerosolized Calfactant (Drug); Solarys (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- ONY
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation and Instillation of Liquid Surfactant |
69; 120 | — |
| SECONDARY Respiratory Support Requirements |
65; 124 | — |
| SECONDARY Air Leak |
14; 11 | — |
Summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Eligibility Criteria
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
- Requiring:
- 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.
Data sourced from ClinicalTrials.gov (NCT03058666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.