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• W2094308889 abstract "Clinical trials are demanding, expensive, and may put patients at risk. Therefore they should be performed only when based on a reasonable hypothesis and when there is the potential for change in clinical care practice. In 1955 the pathophysiology of respiratory distress syndrome (RDS) was not known, and no treatments were known to be effective. Avery and Mead did not identify surfactant deficiency as the primary developmental abnormality causing RDS until 1959. The first experimental demonstration in animal models that surfactant replacement could correct the deficiency was reported by Enhorning and Robertson in 1972. The first report of the clinical efficacy of surfactant treatments in preterm infants was by Fujiwara et al in 1980, and the first randomized-controlled trial of surfactant was reported by Enhorning and Robertson in 1985. In 1955 Briggs randomized 62 infants to an aerosol of Alevaire, a nonionic detergent now called Tyloxapol, or no intervention. Tyloxapol aerosols were being used at the time to deliver streptomycin to children with cavitary tuberculosis and to decrease the viscosity of saliva and puss. Tyloxapol also was being used to treat RDS on the basis of care reports. Detergents have one property in common with pulmonary surfactant—the ability to lower surface tensions at an air-water interface. Detergents also can transiently improve the compliance of the surfactant-deficient lung, but they also can cause lung injury. The hypothesis that a detergent aerosol would improve RDS is not reasonable in retrospect. The trial showed no benefit, which resulted in the clinical benefit in that this therapy was not used subsequently for RDS. Fortunately for these infants in 1955, aerosols deliver very little material to the lungs of infants with RDS, and no harm was done. Tyloxapol appeared again in neonatology as a component in Exosurf, the first synthetic surfactant used to treat RDS. Of note, 26 infants in this trial from 1955 died, and all had autopsies. We envy a 100% autopsy rate in 2005. Clinical trials are demanding, expensive, and may put patients at risk. Therefore they should be performed only when based on a reasonable hypothesis and when there is the potential for change in clinical care practice. In 1955 the pathophysiology of respiratory distress syndrome (RDS) was not known, and no treatments were known to be effective. Avery and Mead did not identify surfactant deficiency as the primary developmental abnormality causing RDS until 1959. The first experimental demonstration in animal models that surfactant replacement could correct the deficiency was reported by Enhorning and Robertson in 1972. The first report of the clinical efficacy of surfactant treatments in preterm infants was by Fujiwara et al in 1980, and the first randomized-controlled trial of surfactant was reported by Enhorning and Robertson in 1985. In 1955 Briggs randomized 62 infants to an aerosol of Alevaire, a nonionic detergent now called Tyloxapol, or no intervention. Tyloxapol aerosols were being used at the time to deliver streptomycin to children with cavitary tuberculosis and to decrease the viscosity of saliva and puss. Tyloxapol also was being used to treat RDS on the basis of care reports. Detergents have one property in common with pulmonary surfactant—the ability to lower surface tensions at an air-water interface. Detergents also can transiently improve the compliance of the surfactant-deficient lung, but they also can cause lung injury. The hypothesis that a detergent aerosol would improve RDS is not reasonable in retrospect. The trial showed no benefit, which resulted in the clinical benefit in that this therapy was not used subsequently for RDS. Fortunately for these infants in 1955, aerosols deliver very little material to the lungs of infants with RDS, and no harm was done. Tyloxapol appeared again in neonatology as a component in Exosurf, the first synthetic surfactant used to treat RDS. Of note, 26 infants in this trial from 1955 died, and all had autopsies. We envy a 100% autopsy rate in 2005." @default.
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• W2094308889 date "2005-07-01" @default.
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• W2094308889 title "A Clinical Trial of Alevaire in Pulmonary Distress of the Newborn Infant" @default.
• W2094308889 doi "https://doi.org/10.1016/j.jpeds.2005.03.012" @default.
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