Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure☆,☆☆,★,★★
Section snippets
Patient Population
Two identical clinical studies were undertaken, and the combined results of the two studies are reported. Each center's institutional review board provided written approval of the protocol, and informed consent was obtained for each patient before randomization into the studies. The studies began on September 1, 1992, and the in-hospital phase was completed on October 23, 1995. Specific entry criteria included the following: (1) a gestational age of 36 completed weeks or older; (2) weight of
Demographic Data
During the study period, 1434 infants weighing at least 2000 gm, with gestational age of at least 36 weeks, not more than 120 hours of age, and with a diagnosis of either MAS, sepsis, or PPHN were screened for study entry at a total of 44 centers. Of these, 1104 (77%) did not meet entrance criteria; 872 infants (60%) were excluded from the study because they did not meet the requirement for 100% supplemental oxygen, were not within the required range for mean OI, or had previously received
Discussion
The results of this large multicenter study have shown that multiple doses of surfactant (beractant) in a population of term newborns with significant respiratory failure consistently and safely reduced the need for ECMO without increasing mortality rate or incidence of severe complications. The overall decrease in the need for ECMO demonstrated with the use of exogenous surfactant in this population was consistent from center to center in spite of variability in management. This study is the
Acknowledgements
The authors gratefully acknowledge the support and assistance of Billie Lou Short, MD. We also gratefully acknowledge the assistance of the Data Monitoring Committee: Reese Clark, MD, Alan Jobe, MD, PhD, P. Pearl O'Rourke, MD, Marilyn Escobedo, MD, and Thomas Fleming, PhD. We also thank James Elberfeld, Margaret Wyza, Karen Bennett, and Phillip Banks for their contributions to this project.
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From the Division of Neonatology and Radiology, Department of Pediatrics, Children's National Medical Center, Washington, D.C.; Department of Pediatrics, The George Washington University School of Medicine and Health Sciences, Washington, D.C.; Ross Products Division, Abbott Laboratories; and Department of Pediatrics, University of Texas Health Science Center at San Antonio. *See Appendix.
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Supported by the Ross Products Division of Abbott Laboratories.
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Reprint requests: Andrea Lotze, MD, Department of Neonatology, Loudun Hospital Center, Leesburg, VA 20176.
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