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| |  Six-Hour Dosing With Beractant No Better Than 12-Hour Dosing for Premature or Extremely Low-Birth-Weight Infants: Presented at PAS By Jill Stein BALTIMORE, Md -- May 4, 2009 -- Changing the dosing interval of beractant intratracheal suspension from 6 hours to 12 hours in infants with extremely low birth weight decreases the amount of surfactant used without compromising respiratory or other outcome measures, researchers reported here at the 2009 Pediatric Academic Societies (PAS) Annual Meeting. "There is little justification for using a 6-hour dosing interval for [beractant]," stated lead investigator Mohammed Attar, MD, University of Michigan, Ann Arbor, Michigan, speaking here at a presentation on May 3. Dr. Attar and colleagues tested beractant dosing at 6- and 12-hour intervals in 217 infants who were either born prematurely before 30 weeks gestation or who had birth weights between 500 and 1,100 g between August 2005 and August 2008. The first dose was given within the first 30 minutes of life, and subsequent doses of surfactant (up to 4 doses) were given if significant mechanical ventilatory support and oxygen supplement were needed. The package insert for beractant recommends redosing at no less than 6 hours from the prior dose, but other animal-derived surfactant preparations are commonly dosed at 12-hour intervals. In June of 2007, Dr. Attar and colleagues changed their retreatment dosing interval from no less than 6 hours to no less than 12 hours. The criteria for subsequent doses of surfactant and the dosing interval have not been based on human pharmacokinetic data, but were empirically recommended by the drug's manufacturers and by investigators, Dr. Attar explained. Results of the retrospective case-control study showed that infants in the 12-hour group consumed fewer surfactant doses per patient. In addition, fewer infants in the 12-hour group required more than 2 doses of surfactant. Infants in the 12-hour group were less frequently treated with more than 2 doses of surfactant (8% vs 21%, P = .012) and consumed similar median doses per patient (1.91 vs 2.11, P = .018) compared to the 6-hour group. The 12-hour and the 6-hour groups also had similar rates of severe intraventricular haemorrhage (13% vs 9%, P = .490), chronic lung disease (23% vs 18%, P = .246), and death (18% vs 14%, P = .443). Both groups also had a similar duration of mechanical ventilation (mean +- standard deviation [SD]: 21 +- 21 vs 18 +- 25 days, P = .477) and total hospital length of stay (mean +- SD: 58 +- 39 vs 59 +- 33 days, P = .942). Rates of necrotising enterocolitis and patent ductus arteriosus were also similar in the 2 groups. "Surfactant replacement therapy is highly effective in reducing mortality and the frequency and severity of respiratory distress syndrome in premature infants," Dr. Attar explained. He added that this study failed to show a benefit from more frequent dosing, and noted that there are substantial cost-savings to 12-hour dosing, given that less drug and healthcare provider time are needed.
[Presentation title: Surfactant Replacement Therapy: Does Dosing Interval Make a Difference? Abstract 3860.172]
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