J Korean Med Sci.  2005 Aug;20(4):591-597. 10.3346/jkms.2005.20.4.591.

Comparison of Clinical Efficacy of Newfactan(R) versus Surfacten(R) for the Treatment of Respiratory Distress Syndrome in the Newborn Infants

• Choi CW
• Hwang JH
• Yoo EJ
• Kim KA
• Koh SY
• Lee YK
• Shim JW
• Lee EK
• Chang W
• Kim SS
• Chang YS
• Park WS
• Shin SM

• KMID: 1712738
• DOI: http://doi.org/10.3346/jkms.2005.20.4.591

Abstract

Newfactan(R) is a domestically developed, bovine lung-derived, semi-synthetic surfactant. The aim of this study was to compare the clinical efficacy of Newfactan(R) with that of Surfacten(R) in the treatment of respiratory distress syndrome (RDS). Newfactan(R) or Surfacten(R) 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(R) and Surfacten(R) in both birth weight groups. We concluded that Newfactan(R) was comparable to Surfacten(R) in the clinical efficacy in the treatment of RDS in both birth weight groups.

Keyword

Newfactan(R); Surfacten(R); Pulmonary Surfactants; Respiratory Distress Syndrome; Newborn

MeSH Terms

Comparative Study
Female
Humans
Infant, Newborn
Lung/drug effects/pathology/physiopathology
Male
Pulmonary Surfactants/*therapeutic use
Research Support, Non-U.S. Gov't
Respiratory Distress Syndrome, Newborn/*drug therapy/mortality
Survival Rate
Time Factors
Treatment Outcome

Figure

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  Fig. 1 The distribution of total subject infants according to the participating hospitals (A) and the distribution of the infants in <1,500 g group according to birth weight (B). The figures designate the number of infants.

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  Fig. 2 The time courses of FiO2 and mean airway pressure (MAP) over the 96 hr after surfactant instillation between Newfactan® group and Surfacten® group in <1,500 g group and ≥1,500 g group. (A) FiO2 in <1,500 g group; (B) Mean airway pressure in <1,500 g group; (C) FiO2 in ≥1,500 g group; (D) mean airway pressure in ≥1,500 g group. There were no significant differences in the time courses of FiO2 and mean airway pressure in both <1,500 g group and ≥1,500 g group.

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  Fig. 3 The time courses of arterial-alveolar oxygen ratio (a/APO2) and ventilatory index (VI) over the 96 hr after surfactant instillation between Newfactan® group and Surfacten® group in <1,500 g group and ≥1,500 g group. (A) a/APO2 in <1,500 g group; (B) VI in <1,500 g group; (C) a/APO2 in ≥1,500 g group; (D) VI in ≥1,500 g group. There were no significant differences in the time courses of a/APO2 and VI in both <1,500 g group and ≥1,500 g group.

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