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Infasurf
At a glance
| Generic name | Infasurf |
|---|---|
| Also known as | Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY), Calfactant |
| Sponsor | Children's Hospital of Philadelphia |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
Approved indications
- Respiratory distress syndrome in the newborn
Common side effects
- Cyanosis
- Airway obstruction
- Bradycardia
- Reflux of surfactant into the endotracheal tube
- Requirement for manual ventilation
- Apnea
- Patent ductus arteriosus
- Intracranial hemorrhage
- Sepsis
- Pulmonary air leaks
- Severe intracranial hemorrhage
- Pulmonary interstitial emphysema
Serious adverse events
- Reintubation
- Severe intracranial hemorrhage
- IVH and periventricular leukomalacia
- Pulmonary hemorrhage
- Necrotizing enterocolitis
Key clinical trials
- Little Lungs Study (PHASE1, PHASE2)
- Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome (PHASE4)
- Non Inferiority Trial Investigating Surfactants Administered Via MIST (PHASE4)
- Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial (PHASE1, PHASE2)
- InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (PHASE3)
- Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients (PHASE3)
- Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
- Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |