TY - JOUR
T1 - Treatment with bovine surfactant in severe acute respiratory distress syndrome in children: A randomized multicenter study
AU - Möller, Jens Christian
AU - Schaible, Thomas
AU - Roll, Claudia
AU - Schiffmann, Jan Holger
AU - Bindl, Lutz
AU - Schrod, Lothar
AU - Reiss, Irwin
AU - Kohl, Martina
AU - Demirakca, Subha
AU - Hentschel, Roland
AU - Paul, Thomas
AU - Vierzig, Anne
AU - Groneck, Peter
AU - Von Seefeld, Heide
AU - Schumacher, Helmut
AU - Gortner, Ludwig
AU - Hörnchen, H.
AU - Merz, U.
AU - Varnholt, V.
AU - Buderus, S.
AU - Scharf, J.
AU - Hanssler, L.
AU - Höhn, T.
AU - Schiffmann, H.
AU - Herting, E.
AU - Rödl, S.
AU - Zobel, G.
AU - Sasse, M.
AU - Simma, B.
AU - Trawöger, R.
AU - Roth, B.
AU - Huth, R. G.
AU - Wippermann, C. F.
AU - Lasch, P.
AU - Voßbeck, S.
AU - Pohlandt, F.
AU - Hofmann, G.
AU - Schmidt, P.
N1 - Funding Information:
Acknowledgements This study was funded by Boehringer Ingel-heim Pharma KG, Ingelheim, Germany. The ARDS Surfactant Study Group includes the following: Departments of Pediatrics/ PICU: University of Aachen: H. Hörnchen MD, PhD, U. Merz MD PhD; Humboldt University of Berlin, PICU: V. Varnholt MD;
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2003/3/1
Y1 - 2003/3/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0037352567&partnerID=8YFLogxK
U2 - 10.1007/s00134-003-1650-1
DO - 10.1007/s00134-003-1650-1
M3 - Journal articles
C2 - 12589529
AN - SCOPUS:0037352567
SN - 0342-4642
VL - 29
SP - 437
EP - 446
JO - Intensive Care Medicine
JF - Intensive Care Medicine
IS - 3
ER -
