InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (NCT05960929) | Clinical Trial Compass
RecruitingPhase 3
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
United States220 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range29 Weeks – 36 Weeks
SexALL
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Inclusion criteria
âś“. Written informed consent obtained by parent or legal representative prior to or after birth
✓. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
✓. Birthweight ≥ 1,000 AND ≤ 3,500 grams
✓. Age ≥ 1 hour AND ≤ 6 hours
✓. 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
âś“. Require CPAP
✓. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
âś“. If subject is \>346/7 weeks' gestation a chest radiograph is required
Exclusion criteria
âś•. Surfactant administration prior to randomization
âś•. Mechanical ventilation prior to randomization
âś•. Major congenital anomaly (suspected or confirmed)
âś•. Abnormality of the airway (suspected or confirmed)
âś•. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)