| 1985 Enhorning, G et al | Prevention of neonatal respiratory distress syndrome by tracheal instillation of surfactant: a randomized clinical trial. Peds. 1985;76:145-153. Summary: In a trial of 72 patients, 39 received a single dose of calf surfactant extract significantly improving gas exchange and reducing severity of RDS. |
| 1985 Kwong, MS et al | Double blind clinical trial of calf lung surfactant extract for the prevention of hyaline membrane disease in extremely premature infants. Peds. 1985;76:585-592. Summary: Instillation of calf lung surfactant extract prior to the first breath in 27 patients showed a significant reduction of incidence of hyaline membrane disease
14% to 54% (P=0.033) versus control. |
| 1991 Kendig, JW et al | A comparison of surfactant as immediate prophylaxis and as rescue therapy in newborns of less than 30 weeks gestation. N. Engl. J. Med. 1991;324:865-871. Summary: Calf lung surfactant extract was given at birth or hours after for newborns less than 30 weeks gestation. The newborns treated at birth had a higher survival, 88% to 80% (P=0.028), versus those treated only after RDS was present. |
| 1993 Kattwinkel, J et al | Prophylactic administration of calf lung surfactant extract is more effective than early treatment of respiratory distress syndrome in neonates of 29 through 32 weeks gestation. Peds. 1993;92:90-98. Summary: The prophylaxis treatment of RDS produced less mortality, need for mechanical ventilation, oxygenation, re-dosing, and development of moderate RDS in the 1248 patients given calf lung surfactant extract. |
| 1996 Hudak, ML et al | A multicenter randomized masked comparison of natural vs synthetic surfactant for the treatment of respiratory distress syndrome. Peds. 1996;128:396-406. Summary: In a blinded study, Infasurf was given to 569 infants with RDS versus 557 given Exosurf. Infasurf had fewer air-leaks than Exosurf, 11% to 21% (P≤0.0001) and a greater reduction in severity of RDS. |
| 1997 Hudak, ML et al | A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome. Peds. 1997;100:39-50. Summary: Infasurf was given to 433 infants and Exosurf to 438 infants<29 weeks gestation at birth. Infants treated with Infasurf had lower incidence of RDS (16% to 42%) and less severe RDS. |
| 1997 Bloom, BT et al | Comparison of Infasurf (calf lung surfactant extract) to Survanta (Beractant) in the treatment and prevention of RDS. Peds. 1997;100:30-38. Summary: Infasurf and Survanta were given in two arms: prophylaxis and treatment for RDS. There were no significant differences seen in the prophylaxis-treated patients. The Infasurf group in the treatment arm had less severe RDS. |
| 1999 Willson, DF et al | Instillation of calf lung surfactant extract (calfactant) is beneficial in pediatric acute hypoxemic respiratory failure. Crit Care Med. 1999;27:188-195. Summary: Infasurf resulted in rapid improvement in oxygenation, earlier extubation and reduction in intensive care duration in 21 children 1 month to 18 years old with acute hypoxemic respiratory failure compared to 21 placebo controls. |
| 2000 Kattwinkel, J et al | High versus low threshold surfactant re-treatment for neonatal respiratory distress syndrome. Peds. 2000;106:282-288. Summary: Equal efficacy observed using 40% FiO2 threshold for re-treatment in uncomplicated RDS patients, but not RDS complicated by asphyxia or possible perinatal infection. |