Multi-center study on effect of calf pulmonary surfactant in prevention and treatment for neonatal respiratory distress syndrome

Objective To investigate the efficacy and safety of calf pulmonary surfactant(made in China) in prevention and treatment for neonatal respiratory distress syndrome(NRDS). Methods A prospective, multi-center controlled clinical study was conducted.A total of 256 patients who came from 7 NICUs were enrolled in this study, with 176 cases who were treated with calf pulmonary surfactant as the observation group and 80 cases refused calf pulmonary surfactant as the control group.The clinical data were observed and compared in the 2 groups, including respiration rate, heart rate, blood pressure, transcutaneous oxygen saturation, arterial blood gas analysis, bedside X-ray of the chest at 0 h and 6 h, the use of oxygen, ventilation and nasal continuous positive airway pressure, the incidence of NRDS and complications, and the length of stay hospital and the costs. Results 1.Compared with the control group, in the observation group receiving the calf pulmonary surfactant treatment, the respiratory rate decreased at different time course(all P 0.05).3.Compared with the control group, in the observation group, the cases of death or the with-drawals declined significantly(20/176 cases vs 25/80 cases), P<0.01; the duration of hospital stay[(35.8±17.4) d vs(42.6±15.7) d] and the costs[(46 568±16 533) yuan vs(56 858±16 334) yuan] were reduced significantly(P<0.01, 0.05). Conclusions Calf pulmonary surfactant can significantly reduce the incidence and mortality of NRDS in very preterm infants, and there has no significant adverse effects. Key words: Calf pulmonary surfactant; Neonatal respiratory distress syndrome; Prevention; Multi-center study; Premature infant; Very low birth weight infants; Extremely low birth weight infants