InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
ONY
220 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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
- Require CPAP
- Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
- If subject is \>346/7 weeks' gestation a chest radiograph is required
Exclusion Criteria8
- Surfactant administration prior to randomization
- Mechanical ventilation prior to randomization
- Major congenital anomaly (suspected or confirmed)
- Abnormality of the airway (suspected or confirmed)
- 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)
- Apgar score \< 3 at 5 minutes of age
- Umbilical cord gas pH \<7.0 or BD \> 10
- Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
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Interventions
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05960929