Treatment with bovine surfactant in severe acute respiratory distress syndrome in children: a randomized multicenter study

Abstract

In the pilot study the PaO(2)/FIO(2) increased by a mean of 100 at 48 h (n=19). A higher PaO(2)/FIO(2) ratio was observed in the surfactant group 2 h after the first dose (58 from baseline vs. 9), at 48 h there was a trend towards a higher ratio (38 from baseline vs. 22). The rate of rescue therapy was significantly lower in the surfactant group. Outcome criteria were not affected by a second surfactant dose (n=11). A significant difference in PaO(2)/FIO(2) in favor of surfactant at 48 h was found in the subgroup with an initial PaO(2)/FIO(2) ratio higher than 65 and in patients without pneumonia. CONCLUSIONS. Surfactant therapy in severe ARDS improves oxygenation immediately after administration. This improvement is sustained only in the subgroup of patients without pneumonia and that with an initial PaO(2)/FIO(2) ratio higher than 65

The Future of Exogenous Surfactant Therapy

“…A number of uncontrolled and controlled studies have documented clinical benefit from exogenous surfactant replacement therapy in term infants, children, and adults with acute respiratory failure (ALI/ARDS) [66][67][68][69]154,[186][187][188][189][190][191][192][193][194][195][196][197][198][199][200] ( Table 2). Of the 19 positive studies listed in Table 2, 9 were controlled trials [67][68][69]154,192,[197][198][199][200] and 10 were uncontrolled treatment trials, in which the risk of selection bias is inherent.…”

“…Of the 19 positive studies listed in Table 2, 9 were controlled trials [67][68][69]154,192,[197][198][199][200] and 10 were uncontrolled treatment trials, in which the risk of selection bias is inherent. An additional 4 positive case series found clinical improvement from surfactant therapy but are not included in Table 2.…”

“…In a large controlled trial, Anzueto et al 64 administered nebulized colfosceril palmitate or placebo to 725 154,192 Findlay et al, 67 Moller et al, 199 Lotze et al, 68,69 Luchetti et al, 197,198 and Amital et al 200 were controlled trials. The remaining 10 studies listed were uncontrolled treatment trials.…”

Surfactant for Pediatric Acute Lung Injury

“…This unblinded trial followed an initial open-label study by the same group demonstrating improved oxygenation in 29 children (0.1-16 yrs) treated with instilled Infasurf® [124]. In addition, a clinical trial by Moller et al [146] reported that children with ARDS showed an immediate improvement in oxygenation and less need for rescue therapy following treatment with Survanta®, although this latter study was underpowered for more definitive outcomes. Most recently, a large blinded, randomized, controlled study by Willson et al [25] in 152 pediatric patients with ALI/ARDS (77 surfactant treated and 75 placebo) yielded very positive results, showing both immediate improvements in oxygenation as well as a significant survival advantage for patients receiving calfactant (Infasurf®) relative to placebo (Table 5).…”

What’s new in surfactant?

“…Several reports have focused on the use of surfactant in acute respiratory distress syndrome (ARDS) or acute lung injury (ALI). In paediatric ARDS/ALI patients, acute improvement of oxygenation is seen with surfactant administration [65, 94,97,[144][145][146]. No additional effects on outcome were noted in the first RCT [97].…”