Comparison of Beractant and Calfactant in a Neonatal Intensive
Purpose: The relative efficacy, complications, and cost of beractant and calfactant were studied.
Methods: All patients admitted to a neonatal intensive care unit between January and November 2001 with an estimated gestational age (EGA) of ≤29 weeks were included in this retrospective study. Neonates with an EGA of >29 weeks who required surfactant treatment because of respiratory distress syndrome (RDS) were also enrolled. The prophylaxis group included all neonates with an EGA of ≤29 weeks who received a prophylactic dose of surfactant within one hour of birth. The rescue group included neonates who did not receive a prophylactic dose, who demonstrated radiographic and clinical signs of RDS, and who received a rescue dose of surfactant.
Results: Of 139 patients reviewed, 107 (77%) were included in the study. No significant difference between the two surfactants in either group was found in mean fraction of inspired oxygen (FiO₂) at 72 hours, time to an FiO₂ of 30%, total number of doses per patient, and complications. The cost of surfactant administered per patient did not differ significantly between the two drugs in each group, but the cost of the amount wasted per patient did. The mean total cost of prophylaxis per patient was thus significantly higher for calfactant ($513) than for beractant ($379).
Conclusion: Beractant and calfactant were similar in terms of efficacy, safety, and total number of doses per patient. However, calfactant was significantly more costly because of greater product waste.

Before the late 1980s, respiratory distress syndrome (RDS), also known as hyaline membrane disease, was the leading cause of morbidity and mortality in preterm neonates. The major complications of RDS are air leaks (pneumothorax and pulmonary emphysema), bronchopulmonary dysplasia, and death.

In 1959, Avery and Mead observed that the lungs of preterm infants with RDS lack pulmonary surfactant, which is critical to maintaining lung inflation. Small randomized controlled trials of surfactants prepared from bovine alveolar lavage or human amniotic fluid were conducted starting in 1980. These studies demonstrated significant decreases in both pneumothorax and mortality with the use of surfactant. Since that time, the beneficial effect of exogenous surfactant replacement therapy on RDS in preterm neonates has been well documented in numerous studies. Surfactant use for prevention and treatment of RDS in preterm neonates is now the standard of care in many institutions.

Two main strategies involving surfactant for RDS in neonates are used in our institution: prevention and treatment. Prevention involves treating high-risk infants with surfactant in the delivery room concurrently with the initiation of ventilation. This is done preferably within 15 minutes of birth. In our institution we consider high-risk infants those with an estimated gestational age (EGA) of ≤29 weeks. More than 70% of neonates born at EGA 28-30 weeks develop RDS. The goal of this prophylactic treatment is to prevent both RDS and any injury to the preterm surfactant-deficient lung that may result from mechanical ventilation. Treatment or "rescue" surfactant use is initiated in infants requiring mechanical ventilation who have a fraction of inspired oxygen (FiO₂) of ≥40%, producing an arterial oxygen pressure (PaO₂) of ≤80 torr. These infants also have confirmed RDS by chest radiography.

Our institution has two surfactants on its formulary, beractant and calfactant. The bovine lung is a source of surfactant for both of these products, and they are similar in composition; only the proportions of the phospholipids and apoproteins differ. To date, only one head-to-head comparison of these two surfactants has been performed to our knowledge. Bloom et al. conducted a prospective, randomized, double-blind, multicenter clinical trial to compare the relative safety and efficacy of calfactant versus beractant in reducing the severity of RDS when given at birth and to infants with established RDS. While the authors did find a significant difference in the infants who required four or more doses of surfactant in the treatment group, they found no significant difference in the number of surfactant doses required between beractant and calfactant in the prevention group. Also, no difference in FiO₂ or mean airway pressure (MAP) was noted 72 hours after the first dose in infants receiving prophylactic surfactant. There was, however, a significant decrease in MAP and FiO₂ in the calfactant group among infants receiving rescue surfactant.

We conducted a retrospective study comparing beractant and calfactant in terms of efficacy, complications, and cost to determine if one of the surfactants could be deleted from our formulary.