A shared protocol for porcine surfactant use in pediatric acute respiratory distress syndrome: a feasibility study

Andrea Wolfler, Marco Piastra, Angela Amigoni, Pierantonio Santuz, Eloisa Gitto, Emanuele Rossetti, Carmine Tinelli, Cinzia Montani, Fabio Savron, Simone Pizzi, Luigia D'amato, Maria Cristina Mondardini, Giorgio Conti, Annalisa De Silvestri

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Pediatric ARDS still represents a difficult challenge in Pediatric Intensive Care Units (PICU). Among different treatments proposed, exogenous surfactant showed conflicting results. Aim of this multicenter retrospective observational study was to evaluate whether poractant alfa use in pediatric ARDS might improve gas exchange in children less than 2 years old, according to a shared protocol.

METHODS: The study was carried out in fourteen Italian PICUs after dissemination of a standardized protocol for surfactant administration within the Italian PICU network. The protocol provides the administration of surfactant (50 mg/kg) divided in two doses: the first dose is used as a bronchoalveolar lavage while the second as supplementation. Blood gas exchange variations before and after surfactant use were recorded.

RESULTS: Sixty-nine children, age 0-24 months, affected by Acute Respiratory Distress Syndrome treated with exogenous porcine surfactant were enrolled. Data collection consisted of patient demographics, respiratory variables and arterial blood gas analysis. The most frequent reasons for PICU admission were acute respiratory failure, mainly bronchiolitis and pneumonia, and septic shock. Fifty-four children (78.3%) had severe ARDS (define by oxygen arterial pressure and inspired oxygen fraction ratio (P/F) < 100), 15 (21.7%) had moderate ARDS (100 < P/F < 200). PO2, P/F, Oxygenation Index (OI) and pH showed a significant improvement after surfactant use with respect to baseline (p < 0.001 at each included time-point for each parameter). No significant difference in blood gas variations were observed among four different subgroups of diseases (bronchiolitis, pneumonia, septic shock and others). Overall, 11 children died (15.9%) and among these, 10 (90.9%) had complex chronic conditions. Two children (18.2%) died while being treated with Extracorporeal Membrane Oxygenation (ECMO). Mortality for severe pARDS was 20.4%.

CONCLUSION: The use of porcine Surfactant improves oxygenation, P/F ratio, OI and pH in a population of children with moderate or severe pARDS caused by multiple diseases. A shared protocol seems to be a good option to obtain the same criteria of enrollment among different PICUs and define a unique way of use and administration of the drug for future studies.

Original languageEnglish
Pages (from-to)203
JournalBMC Pediatrics
Volume19
Issue number1
DOIs
Publication statusPublished - Jun 18 2019

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Adult Respiratory Distress Syndrome
Feasibility Studies
Surface-Active Agents
Swine
Pediatrics
Pediatric Intensive Care Units
Bronchiolitis
Gases
Septic Shock
Pneumonia
Oxygen
Extracorporeal Membrane Oxygenation
Blood Gas Analysis
Bronchoalveolar Lavage
Respiratory Insufficiency
Observational Studies
Arterial Pressure
Retrospective Studies
Demography
Mortality

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A shared protocol for porcine surfactant use in pediatric acute respiratory distress syndrome : a feasibility study. / Wolfler, Andrea; Piastra, Marco; Amigoni, Angela; Santuz, Pierantonio; Gitto, Eloisa; Rossetti, Emanuele; Tinelli, Carmine; Montani, Cinzia; Savron, Fabio; Pizzi, Simone; D'amato, Luigia; Mondardini, Maria Cristina; Conti, Giorgio; De Silvestri, Annalisa.

In: BMC Pediatrics, Vol. 19, No. 1, 18.06.2019, p. 203.

Research output: Contribution to journalArticle

Wolfler, Andrea ; Piastra, Marco ; Amigoni, Angela ; Santuz, Pierantonio ; Gitto, Eloisa ; Rossetti, Emanuele ; Tinelli, Carmine ; Montani, Cinzia ; Savron, Fabio ; Pizzi, Simone ; D'amato, Luigia ; Mondardini, Maria Cristina ; Conti, Giorgio ; De Silvestri, Annalisa. / A shared protocol for porcine surfactant use in pediatric acute respiratory distress syndrome : a feasibility study. In: BMC Pediatrics. 2019 ; Vol. 19, No. 1. pp. 203.
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abstract = "BACKGROUND: Pediatric ARDS still represents a difficult challenge in Pediatric Intensive Care Units (PICU). Among different treatments proposed, exogenous surfactant showed conflicting results. Aim of this multicenter retrospective observational study was to evaluate whether poractant alfa use in pediatric ARDS might improve gas exchange in children less than 2 years old, according to a shared protocol.METHODS: The study was carried out in fourteen Italian PICUs after dissemination of a standardized protocol for surfactant administration within the Italian PICU network. The protocol provides the administration of surfactant (50 mg/kg) divided in two doses: the first dose is used as a bronchoalveolar lavage while the second as supplementation. Blood gas exchange variations before and after surfactant use were recorded.RESULTS: Sixty-nine children, age 0-24 months, affected by Acute Respiratory Distress Syndrome treated with exogenous porcine surfactant were enrolled. Data collection consisted of patient demographics, respiratory variables and arterial blood gas analysis. The most frequent reasons for PICU admission were acute respiratory failure, mainly bronchiolitis and pneumonia, and septic shock. Fifty-four children (78.3{\%}) had severe ARDS (define by oxygen arterial pressure and inspired oxygen fraction ratio (P/F) < 100), 15 (21.7{\%}) had moderate ARDS (100 < P/F < 200). PO2, P/F, Oxygenation Index (OI) and pH showed a significant improvement after surfactant use with respect to baseline (p < 0.001 at each included time-point for each parameter). No significant difference in blood gas variations were observed among four different subgroups of diseases (bronchiolitis, pneumonia, septic shock and others). Overall, 11 children died (15.9{\%}) and among these, 10 (90.9{\%}) had complex chronic conditions. Two children (18.2{\%}) died while being treated with Extracorporeal Membrane Oxygenation (ECMO). Mortality for severe pARDS was 20.4{\%}.CONCLUSION: The use of porcine Surfactant improves oxygenation, P/F ratio, OI and pH in a population of children with moderate or severe pARDS caused by multiple diseases. A shared protocol seems to be a good option to obtain the same criteria of enrollment among different PICUs and define a unique way of use and administration of the drug for future studies.",
author = "Andrea Wolfler and Marco Piastra and Angela Amigoni and Pierantonio Santuz and Eloisa Gitto and Emanuele Rossetti and Carmine Tinelli and Cinzia Montani and Fabio Savron and Simone Pizzi and Luigia D'amato and Mondardini, {Maria Cristina} and Giorgio Conti and {De Silvestri}, Annalisa",
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T1 - A shared protocol for porcine surfactant use in pediatric acute respiratory distress syndrome

T2 - a feasibility study

AU - Wolfler, Andrea

AU - Piastra, Marco

AU - Amigoni, Angela

AU - Santuz, Pierantonio

AU - Gitto, Eloisa

AU - Rossetti, Emanuele

AU - Tinelli, Carmine

AU - Montani, Cinzia

AU - Savron, Fabio

AU - Pizzi, Simone

AU - D'amato, Luigia

AU - Mondardini, Maria Cristina

AU - Conti, Giorgio

AU - De Silvestri, Annalisa

PY - 2019/6/18

Y1 - 2019/6/18

N2 - BACKGROUND: Pediatric ARDS still represents a difficult challenge in Pediatric Intensive Care Units (PICU). Among different treatments proposed, exogenous surfactant showed conflicting results. Aim of this multicenter retrospective observational study was to evaluate whether poractant alfa use in pediatric ARDS might improve gas exchange in children less than 2 years old, according to a shared protocol.METHODS: The study was carried out in fourteen Italian PICUs after dissemination of a standardized protocol for surfactant administration within the Italian PICU network. The protocol provides the administration of surfactant (50 mg/kg) divided in two doses: the first dose is used as a bronchoalveolar lavage while the second as supplementation. Blood gas exchange variations before and after surfactant use were recorded.RESULTS: Sixty-nine children, age 0-24 months, affected by Acute Respiratory Distress Syndrome treated with exogenous porcine surfactant were enrolled. Data collection consisted of patient demographics, respiratory variables and arterial blood gas analysis. The most frequent reasons for PICU admission were acute respiratory failure, mainly bronchiolitis and pneumonia, and septic shock. Fifty-four children (78.3%) had severe ARDS (define by oxygen arterial pressure and inspired oxygen fraction ratio (P/F) < 100), 15 (21.7%) had moderate ARDS (100 < P/F < 200). PO2, P/F, Oxygenation Index (OI) and pH showed a significant improvement after surfactant use with respect to baseline (p < 0.001 at each included time-point for each parameter). No significant difference in blood gas variations were observed among four different subgroups of diseases (bronchiolitis, pneumonia, septic shock and others). Overall, 11 children died (15.9%) and among these, 10 (90.9%) had complex chronic conditions. Two children (18.2%) died while being treated with Extracorporeal Membrane Oxygenation (ECMO). Mortality for severe pARDS was 20.4%.CONCLUSION: The use of porcine Surfactant improves oxygenation, P/F ratio, OI and pH in a population of children with moderate or severe pARDS caused by multiple diseases. A shared protocol seems to be a good option to obtain the same criteria of enrollment among different PICUs and define a unique way of use and administration of the drug for future studies.

AB - BACKGROUND: Pediatric ARDS still represents a difficult challenge in Pediatric Intensive Care Units (PICU). Among different treatments proposed, exogenous surfactant showed conflicting results. Aim of this multicenter retrospective observational study was to evaluate whether poractant alfa use in pediatric ARDS might improve gas exchange in children less than 2 years old, according to a shared protocol.METHODS: The study was carried out in fourteen Italian PICUs after dissemination of a standardized protocol for surfactant administration within the Italian PICU network. The protocol provides the administration of surfactant (50 mg/kg) divided in two doses: the first dose is used as a bronchoalveolar lavage while the second as supplementation. Blood gas exchange variations before and after surfactant use were recorded.RESULTS: Sixty-nine children, age 0-24 months, affected by Acute Respiratory Distress Syndrome treated with exogenous porcine surfactant were enrolled. Data collection consisted of patient demographics, respiratory variables and arterial blood gas analysis. The most frequent reasons for PICU admission were acute respiratory failure, mainly bronchiolitis and pneumonia, and septic shock. Fifty-four children (78.3%) had severe ARDS (define by oxygen arterial pressure and inspired oxygen fraction ratio (P/F) < 100), 15 (21.7%) had moderate ARDS (100 < P/F < 200). PO2, P/F, Oxygenation Index (OI) and pH showed a significant improvement after surfactant use with respect to baseline (p < 0.001 at each included time-point for each parameter). No significant difference in blood gas variations were observed among four different subgroups of diseases (bronchiolitis, pneumonia, septic shock and others). Overall, 11 children died (15.9%) and among these, 10 (90.9%) had complex chronic conditions. Two children (18.2%) died while being treated with Extracorporeal Membrane Oxygenation (ECMO). Mortality for severe pARDS was 20.4%.CONCLUSION: The use of porcine Surfactant improves oxygenation, P/F ratio, OI and pH in a population of children with moderate or severe pARDS caused by multiple diseases. A shared protocol seems to be a good option to obtain the same criteria of enrollment among different PICUs and define a unique way of use and administration of the drug for future studies.

U2 - 10.1186/s12887-019-1579-3

DO - 10.1186/s12887-019-1579-3

M3 - Article

C2 - 31215483

VL - 19

SP - 203

JO - BMC Pediatrics

JF - BMC Pediatrics

SN - 1471-2431

IS - 1

ER -