Infasurf Trials Bibliography

1985 Enhorning, G et alPrevention 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 alDouble 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 alA 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 alProphylactic 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 alA 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 alA 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 alComparison 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 alInstillation 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 alHigh 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.