ObjectiveOpen-label trial of the safety and short-term efficacy of calf's lung surfactant in pediatric respiratory failure.DesignMulti-institutional, uncontrolled, observational trial.SettingSix pediatric intensive care units of tertiary medical centers.Patientsor=to7.InterventionsUp to four doses of intratracheal surfactant (80 mL/m2).Measurements and Main ResultsVentilator parameters, arterial blood gases, and derived oxygenation and ventilation indices were recorded before, and at intervals after, surfactant administration. Complications and outcome measures were also noted. There was immediate improvement in oxygenation and moderation of ventilator support associated with surfactant administration in 24 of 29 patients. A modest but statistically insignificant effect was seen with subsequent doses. The only complications occurred in three patients who developed airleaks, two of which were coincident with surfactant administration. The overall mortality rate was 14%, which compares favorably with other published series.ConclusionsAdministration of calf's lung surfactant appears to be safe and is associated with rapid improvement in oxygenation and moderation of ventilator support in children with acute hypoxemic respiratory failure. These results set the stage for a randomized, controlled study.(Crit Care Med 1996; 24:1316-1322)