Clinical Trial of Domestically Developed Bovine Lung Surfactant YY-38 in Neonatal Respiratory Distress Syndrome

ABSTRACT

PURPOSE: We previously reported modified bovine lung surfactant YY-38(Newfactan ) had a low surface tension, good hysteresis, and exhibited good pressure-volume curve in animal experiment(J Korean Pediatr Asso 1997;40771-85). We performed multicenter clinical trial of Newfactan in neonatal RDS. METHODS: Seventy-seven infants with RDS(GA 31.8+/-2.9 wks and BW 1,809+/-592 gm) in 4 NICU were enrolled. After administration of Newfactan , we analyzed ventilator parameters and outcomes in 71 infants excluding mortality cases(n=6), and also compared risk factors between response(n=53) and redosing group(n=18). RESULTS: Newfactan was administered at 6.8+/-7.2 hr after birth. Ventilator parameters such as FiO2, alveolar-arterial oxygen difference(a-A PO2) and oxygenation index(OI) except mean airway pressure(MAP) were significantly improved from six hours after administration. All parameters were improved at 24 hours after administration and persisted for 5 days. Outcomes were as follows; PDA(n=24), BPD(n=16), IVH(n=13), sepsis(n=9), ROP(n=7), pneumothorax(n=4) NEC(n=3), PIE(n=2), and pulmonary hemorrhage(n=1). All patients survived 30 days after birth. Redosing rate was 25%. The incidence of PDA was greater in redosing(56%) than in response group(26 %)(P=0.025). CONCLUSION: In prospective multicenter clinical trial, Newfactan was effective in the treatmentof RDS.