Phase 3
Completed N=477
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Source: ClinicalTrials.gov NCT03058666 ↗Enrolled (actual)
477
Serious AEs
5.7%
Results posted
May 2024
Primary outcomePrimary: Intubation and Instillation of Liquid Surfactant — 69; 120 Participants
◆ Published Evidence
Established
91citations · ~15 / year
Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.
Summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Linked Publications
-
Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.