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01-03-2003 | Neonatal and Pediatric Intensive Care

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

Authors: Jens Christian Möller, Thomas Schaible, Claudia Roll, Jan-Holger Schiffmann, Lutz Bindl, Lothar Schrod, Irwin Reiss, Martina Kohl, Subha Demirakca, Roland Hentschel, Thomas Paul, Anne Vierzig, Peter Groneck, Heide von Seefeld, Helmut Schumacher, Ludwig Gortner, and the Surfactant ARDS Study Group

Published in: Intensive Care Medicine | Issue 3/2003

Abstract

Objective

To determine whether bovine surfactant given in cases of severe pediatric acute respiratory distress syndrome (ARDS) improves oxygenation.

Design

Single-center study with 19 patients, followed by a multicenter randomized comparison of surfactant with a standardized treatment algorithm. Primary endpoint PaO₂/FIO₂ at 48 h, secondary endpoints: PaO₂/FIO₂ at 2, 4, 12, and 24 h, survival, survival without rescue, days on ventilator, subgroups analyzed by analysis of variance to identify patients who might benefit from surfactant

Setting

Multicenter study in 19 reference centers for ARDS.

Patients

Children after the 44th postconceptional week and under 14 years old, admitted for at least 4 h, ventilated for 12–120 h, and without heart failure or chronic lung disease. In the multicenter study 35 patients were recruited; 20 were randomized to the surfactant group and 15 to the nonsurfactant group. Decreasing recruitment of patients led to a preliminary end of this study.

Interventions

Administration of 100 mg/kg bovine surfactant intratracheally under continuous ventilation and PEEP, as soon as the PaO₂/FIO₂ ratio dropped to less than 100 for 2 h (in the pilot study increments of 50 mg/kg as long as the PaO₂/FIO₂ did not increase by 20%). A second equivalent dose within 48 h was permitted.

Results

In the pilot study the PaO₂/FIO₂ increased by a mean of 100 at 48 h (n=19). A higher PaO₂/FIO₂ 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 PaO₂/FIO₂ in favor of surfactant at 48 h was found in the subgroup with an initial PaO₂/FIO₂ 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 PaO₂/FIO₂ ratio higher than 65

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Title: Treatment with bovine surfactant in severe acute respiratory distress syndrome in children: a randomized multicenter study
Authors: Jens Christian Möller
Thomas Schaible
Claudia Roll
Jan-Holger Schiffmann
Lutz Bindl
Lothar Schrod
Irwin Reiss
Martina Kohl
Subha Demirakca
Roland Hentschel
Thomas Paul
Anne Vierzig
Peter Groneck
Heide von Seefeld
Helmut Schumacher
Ludwig Gortner
and the Surfactant ARDS Study Group
Publication date: 01-03-2003
Publisher: Springer-Verlag
Published in: Intensive Care Medicine / Issue 3/2003
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-003-1650-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Objective

Design

Setting

Patients

Interventions

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Design

Setting

Patients

Interventions

Results

Conclusions

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