Comparison of clinical efficacy of Newfactan versus Surfacten for the treatment of respiratory distress syndrome in the newborn infants.
Newfactan is a domestically developed, bovine lung-derived, semi-synthetic surfactant. The aim of this study was to compare the clinical efficacy of Newfactan with that of Surfacten in the treatment of respiratory distress syndrome (RDS). Newfactan or Surfacten was randomly allocated to 492 newborn infants who were diagnosed as RDS and required surfactant instillation in four participating hospitals. The comparisons were made individually in two subsets of infants by birth weight (<1,500 g group [n=253] and > or =1,500 g group [n=239]). Short-term responses to surfactant and acute complications, such as the total doses of surfactant instilled, response type, extubation rate, ventilator settings, changes in respiratory parameters, air leak, patent ductus arteriosus, pulmonary hemorrhage, and intraventricular hemorrhage, and mortality during the 96 hr after surfactant instillation were measured. Long-term outcome and complications, such as total duration of intubation, bronchopulmonary dysplasia and periventricular leukomalacia, and ultimate mortality were measured. There were no significant differences in demographic and perinatal variables, shortterm responses to surfactant and acute complications, and long-term outcome and complications between Newfactan and Surfacten in both birth weight groups. We concluded that Newfactan was comparable to Surfacten in the clinical efficacy in the treatment of RDS in both birth weight groups.
Choi
Chang Won
CW
Department of Pediatrics, Samsung Seoul Hospital, Samsung Cheil Hospital, Korea.
Hwang
Jong Hee
JH
Yoo
Eun Jung
EJ
Kim
Kyung Ah
KA
Koh
Sun Young
SY
Lee
Yeon Kyung
YK
Shim
Jae Won
JW
Lee
Eun Kyung
EK
Chang
Wook
W
Kim
Sung Shin
SS
Chang
Yun Sil
YS
Park
Won Soon
WS
Shin
Son Moon
SM
D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008168:Lung / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D008297:Male; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D011663:Pulmonary Surfactants