The most common adverse reactions associated with Infasurf (calfactant) dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.
The incidence of common complications of prematurity and RDS in the four controlled Infasurf (calfactant) trials are presented in Table 3. Prophylaxis and treatment study results for each surfactant are combined.
Table 3 - Common Complications of Prematurity and RDS in Controlled Trials
|Patent ductus arteriosus||47||48||45||48|
|Severe intracranial hemorrhage a||12||10||9||7|
|IVH and PVLb||7||3||5||5|
|Pulmonary air leaks||12||22||15||15|
|Pulmonary interstitial emphysema||7||17||10||10|
|a Grade III and IV by the method of Papile.
b Patients with both intraventricular hemorrhage and periventricular leukomalacia.
Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf (calfactant) vs. Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf (calfactant) and Exosurf Neonatal® patients.