All issues > Volume 42(4); 1999

Original Article

J Korean Pediatr Soc. 1999;42(4):472-483. Published online April 15, 1999.

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

Chul C Lee¹, Jeong Nyun JN Kim², Min-Soo MS Park¹, Moon Sung MS Park³, Shin Won SW Yoon¹, Wook W Chang¹, Ran R Namgung¹, Kook In KI Park¹, Dong-Gwan DG Han¹

¹Department of Pediatrics, Severance Hosp., Yongdong Severance Hosp., Yonsei University
²Department of Pediatrics, Sanggye-Paik Hospital, Inje University College of Medicine
³Department of Pediatrics, Ajou University School of Medicine

Correspondence Chul C Lee ,Email: 1

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;40:771-85). We performed multicenter clinical trial of NewfactanⓇ in neonatal RDS.
Methods
: Seventy-seven infants with RDS(GA 31.8¡¾2.9 wks and BW 1,809¡¾592 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¡¾7.2 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 treatment of RDS.

Keywords :Clinical trial, Modified bovine lung surfactant, NewfactanⓇ, Respiratory distress syndrome