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ORIGINAL ARTICLE
Korean J Pediatr 1999 April;42(4) :472-483.
Clinical Trial of Domestically Developed Bovine Lung Surfactant YY-38 in Neonatal Respiratory Distress Syndrome
Chul Lee (Lee C)1, Jeong Nyun Kim (Kim JN)2, Min-Soo Park (Park MS)1, Moon Sung Park (Park MS)3, Shin Won Yoon (Yoon SW)1, Wook Chang (Chang W)1, Ran Namgung (Namgung R)1, Kook In Park (Park KI)1, Dong-Gwan Han (Han DG)1
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
Corresponding Author: Chul Lee ,Email: 1
Copyright © 1999 by The Korean Pediatric Society
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 31.82.9 wks and BW 1,809592 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 6.87.2 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
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