InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
ONY
Summary
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Description
This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™. The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered thr…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Inclusion criteria include ALL of the following: 1. Written informed consent obtained by parent or legal representative prior to or after birth 2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks 3. Birthweight ≥ 1,000 AND ≤ 3,500 grams 4. Age ≥ 1 hour AND ≤ 6 hours 5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation 6. Require CPAP 7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4 8. If subject…
Interventions
- Combination ProductInfasurf Aero™
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Locations (10)
- St. Josephs Hospital and Medical CenterPhoenix, Arizona
- Phoenix Children'sPhoenix, Arizona
- Sharp Mary Birch Hospital for Women & NewbornsSan Diego, California
- University of Florida -JacksonvilleJacksonville, Florida
- Kapi'olani Medical Center for Women & ChildrenHonolulu, Hawaii
- Jersey Shore University Medical CenterNeptune City, New Jersey