[Early use of calf pulmonary surfactant in late preterm and full-term infants with respiratory distress syndrome: a randomized controlled trial].

OBJECTIVE: To evaluate the efficacy of calf pulmonary surfactant (PS) in the treatment of respiratory distress syndrome (RDS) in late preterm and full-term infants.

METHODS: A randomized controlled trial was designed to evaluate the efficacy of calf PS intratracheally given at different times and doses in infants with RDS who had a gestational age of ≥35 weeks and an oxygenation index (OI) of 10-20. The subjects were randomly assigned to treatment group 1 (n=58), treatment group 2 (n=58), and control group (n=59). Treatment group 1 was given PS (50 mg/kg) within 6 hours after admission. Treatment group 2 was given PS (70 mg/kg) within 6 hours after admission. The control group was not given PS within 6 hours after admission and was given PS (50 mg/kg) over 6 hours after admission if having no remission by conventional therapy including mechanical ventilation. For each group, a second dose of PS (50 mg/kg) was given if no remission was observed within 12 hours after the first administration.

RESULTS: There were no significant differences in mortality between the three groups. Treatment group 2 had lower hospitalization expense and shorter duration of mechanical ventilation compared with treatment group 1, and treatment group 1 had lower hospitalization expense and shorter duration of mechanical ventilation compared with the control group. The incidence of ventilator-associated pneumonia and length of hospital stay in treatment group 2 was lower than those in treatment group 1 and control group. Compared with the control group, Treatment groups 1 and 2 showed decreases in 2 or more times of PS use, maximum OI, duration of continuous positive airway pressure treatment, and incidence of air leak syndrome and pulmonary hypertension.

CONCLUSIONS: Early use of sufficient PS in late preterm and full-term infants with RDS can reduce complications, secondary use of PS, duration of mechanical ventilation and length of hospital stay, and hospitalization expense.