A multicenter clinical trial of the surfactant replacement therapy for neonatal respiratory distress syndrome

Abstract

Objective To evaluate the efficacy and safety of pulmonary surfactant (PS) in the replacement therapy for neonatal respiratory distress syndrome (NRDS) . Methods Forty-two NRDS infants from four hospitals in Beijing were treated with curosurf which is one of the PS. The changes of the lung function and lung aeration after the therapy and some common complications in premature infants were observed. Results Thirty minutes after the administration of curosurf, PaO2 significantly increased from (44 ± 14) mm Hg to (102 ±59) mm Hg, a/APO2 from 0.11 ± 0.05 to 0.28 ± 0.18. PaO2 and a/APO2 remained higher levels until 10 days after the administration and were significantly different from the levels before the treatment (P < 0.01) . After 30minutes of the administration, PaCO2 decreased from (54 ± 17) mm Hg to (45 ± 13) mm Hg (P < 0.05). After 12 hours of the administration, chest X-ray showed a significant improvement in lung aeration. After 24 hours, the mechanical ventilation frequency decreased significantly from (48 ± 8) times/min to (42 ± 12) times/min, the peak inspiratory pressure decreased from (22.2±3.6) mm Hg to (19.4 ± 2.8) mm Hg, and the mean airway pressure from (11.8 ± 2.0) mm Hg to (9.9 ± 2.2) mm Hg. The incidences of the intracranial hemorrhage, pneumothorax, patent ductus arteriousus and pneumonia were 28%, 7%, 35% and 79%, respectively. Conclusion Curosurf could rapidly and effectively improve the lung function and lung aeration in NRDS infants. Key words: Pulmonary surfactants; Infant, newborn; Respiratory distress syndrome; Therapy