Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: Study protocol for a randomized controlled trial

Giovanni Vento, Roberta Pastorino, Luca Boni, Francesco Cota, Virgilio Carnielli, Filip Cools, Carlo Dani, Fabio Mosca, Jane Pillow, Graeme Polglase, Paolo Tagliabue, Anton H. van Kaam, Maria Luisa Ventura, Milena Tana, Chiara Tirone, Claudia Aurilia, Alessandra Lio, Cinzia Ricci, Alessandro Gambacorta, Chiara ConsigliDanila D'Onofrio, Camilla Gizzi, Luca Massenzi, Viviana Cardilli, Alessandra Casati, Roberto Bottino, Federica Pontiggia, Elena Ciarmoli, Stefano Martinelli, Laura Ilardi, Mariarosa Colnaghi, Piero Giuseppe Matassa, Valentina Vendettuoli, Paolo Villani, Francesca Fusco, Diego Gazzolo, Alberto Ricotti, Federica Ferrero, Ilaria Stasi, Rosario Magaldi, Gianfranco Maffei, Giuseppe Presta, Roberto Perniola, Francesco Messina, Giovanna Montesano, Chiara Poggi, Lucio Giordano, Enza Roma, Carolina Grassia, Gaetano Ausanio, Fabrizio Sandri, Giovanna Mescoli, Francesco Giura, Giampaolo Garani, Agostina Solinas, Maria Lucente, Gabriella Nigro, Antonello Del Vecchio, Flavia Petrillo, Luigi Orfeo, Lidia Grappone, Lorenzo Quartulli, Antonio Scorrano, Hubert Messner, Alex Staffler, Giancarlo Gargano, Eleonora Balestri, Stefano Nobile, Caterina Cacace, Valerio Meli, Sara Dallaglio, Betta Pasqua, Loretta Mattia, Eloisa Gitto, Marcello Vitaliti, Maria Paola Re, Stefania Vedovato, Alessandra Grison, Alberto Berardi, Francesco Torcetta, Isotta Guidotti, Sandra di Fabio, Eugenia Maranella, Isabella Mondello, Stefano Visentin, Francesca Tormena

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. Methods/design: In this study, 206 spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge. Trial registration: ClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015.

Original languageEnglish
Article number414
JournalTrials
Volume17
Issue number1
DOIs
Publication statusPublished - Aug 18 2016

Fingerprint

Surface-Active Agents
Randomized Controlled Trials
Newborn Infant
High-Frequency Ventilation
Continuous Positive Airway Pressure
Lung
Artificial Respiration
Respiration
Newborn Respiratory Distress Syndrome
Functional Residual Capacity
Economic Inflation
Intubation
Premature Infants
Pressure
Pregnancy

Keywords

  • HFOV
  • INSURE
  • Lung recruitment
  • Preterm infants

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome : Study protocol for a randomized controlled trial. / Vento, Giovanni; Pastorino, Roberta; Boni, Luca; Cota, Francesco; Carnielli, Virgilio; Cools, Filip; Dani, Carlo; Mosca, Fabio; Pillow, Jane; Polglase, Graeme; Tagliabue, Paolo; van Kaam, Anton H.; Ventura, Maria Luisa; Tana, Milena; Tirone, Chiara; Aurilia, Claudia; Lio, Alessandra; Ricci, Cinzia; Gambacorta, Alessandro; Consigli, Chiara; D'Onofrio, Danila; Gizzi, Camilla; Massenzi, Luca; Cardilli, Viviana; Casati, Alessandra; Bottino, Roberto; Pontiggia, Federica; Ciarmoli, Elena; Martinelli, Stefano; Ilardi, Laura; Colnaghi, Mariarosa; Matassa, Piero Giuseppe; Vendettuoli, Valentina; Villani, Paolo; Fusco, Francesca; Gazzolo, Diego; Ricotti, Alberto; Ferrero, Federica; Stasi, Ilaria; Magaldi, Rosario; Maffei, Gianfranco; Presta, Giuseppe; Perniola, Roberto; Messina, Francesco; Montesano, Giovanna; Poggi, Chiara; Giordano, Lucio; Roma, Enza; Grassia, Carolina; Ausanio, Gaetano; Sandri, Fabrizio; Mescoli, Giovanna; Giura, Francesco; Garani, Giampaolo; Solinas, Agostina; Lucente, Maria; Nigro, Gabriella; Del Vecchio, Antonello; Petrillo, Flavia; Orfeo, Luigi; Grappone, Lidia; Quartulli, Lorenzo; Scorrano, Antonio; Messner, Hubert; Staffler, Alex; Gargano, Giancarlo; Balestri, Eleonora; Nobile, Stefano; Cacace, Caterina; Meli, Valerio; Dallaglio, Sara; Pasqua, Betta; Mattia, Loretta; Gitto, Eloisa; Vitaliti, Marcello; Re, Maria Paola; Vedovato, Stefania; Grison, Alessandra; Berardi, Alberto; Torcetta, Francesco; Guidotti, Isotta; di Fabio, Sandra; Maranella, Eugenia; Mondello, Isabella; Visentin, Stefano; Tormena, Francesca.

In: Trials, Vol. 17, No. 1, 414, 18.08.2016.

Research output: Contribution to journalArticle

Vento, G, Pastorino, R, Boni, L, Cota, F, Carnielli, V, Cools, F, Dani, C, Mosca, F, Pillow, J, Polglase, G, Tagliabue, P, van Kaam, AH, Ventura, ML, Tana, M, Tirone, C, Aurilia, C, Lio, A, Ricci, C, Gambacorta, A, Consigli, C, D'Onofrio, D, Gizzi, C, Massenzi, L, Cardilli, V, Casati, A, Bottino, R, Pontiggia, F, Ciarmoli, E, Martinelli, S, Ilardi, L, Colnaghi, M, Matassa, PG, Vendettuoli, V, Villani, P, Fusco, F, Gazzolo, D, Ricotti, A, Ferrero, F, Stasi, I, Magaldi, R, Maffei, G, Presta, G, Perniola, R, Messina, F, Montesano, G, Poggi, C, Giordano, L, Roma, E, Grassia, C, Ausanio, G, Sandri, F, Mescoli, G, Giura, F, Garani, G, Solinas, A, Lucente, M, Nigro, G, Del Vecchio, A, Petrillo, F, Orfeo, L, Grappone, L, Quartulli, L, Scorrano, A, Messner, H, Staffler, A, Gargano, G, Balestri, E, Nobile, S, Cacace, C, Meli, V, Dallaglio, S, Pasqua, B, Mattia, L, Gitto, E, Vitaliti, M, Re, MP, Vedovato, S, Grison, A, Berardi, A, Torcetta, F, Guidotti, I, di Fabio, S, Maranella, E, Mondello, I, Visentin, S & Tormena, F 2016, 'Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: Study protocol for a randomized controlled trial', Trials, vol. 17, no. 1, 414. https://doi.org/10.1186/s13063-016-1498-7
Vento, Giovanni ; Pastorino, Roberta ; Boni, Luca ; Cota, Francesco ; Carnielli, Virgilio ; Cools, Filip ; Dani, Carlo ; Mosca, Fabio ; Pillow, Jane ; Polglase, Graeme ; Tagliabue, Paolo ; van Kaam, Anton H. ; Ventura, Maria Luisa ; Tana, Milena ; Tirone, Chiara ; Aurilia, Claudia ; Lio, Alessandra ; Ricci, Cinzia ; Gambacorta, Alessandro ; Consigli, Chiara ; D'Onofrio, Danila ; Gizzi, Camilla ; Massenzi, Luca ; Cardilli, Viviana ; Casati, Alessandra ; Bottino, Roberto ; Pontiggia, Federica ; Ciarmoli, Elena ; Martinelli, Stefano ; Ilardi, Laura ; Colnaghi, Mariarosa ; Matassa, Piero Giuseppe ; Vendettuoli, Valentina ; Villani, Paolo ; Fusco, Francesca ; Gazzolo, Diego ; Ricotti, Alberto ; Ferrero, Federica ; Stasi, Ilaria ; Magaldi, Rosario ; Maffei, Gianfranco ; Presta, Giuseppe ; Perniola, Roberto ; Messina, Francesco ; Montesano, Giovanna ; Poggi, Chiara ; Giordano, Lucio ; Roma, Enza ; Grassia, Carolina ; Ausanio, Gaetano ; Sandri, Fabrizio ; Mescoli, Giovanna ; Giura, Francesco ; Garani, Giampaolo ; Solinas, Agostina ; Lucente, Maria ; Nigro, Gabriella ; Del Vecchio, Antonello ; Petrillo, Flavia ; Orfeo, Luigi ; Grappone, Lidia ; Quartulli, Lorenzo ; Scorrano, Antonio ; Messner, Hubert ; Staffler, Alex ; Gargano, Giancarlo ; Balestri, Eleonora ; Nobile, Stefano ; Cacace, Caterina ; Meli, Valerio ; Dallaglio, Sara ; Pasqua, Betta ; Mattia, Loretta ; Gitto, Eloisa ; Vitaliti, Marcello ; Re, Maria Paola ; Vedovato, Stefania ; Grison, Alessandra ; Berardi, Alberto ; Torcetta, Francesco ; Guidotti, Isotta ; di Fabio, Sandra ; Maranella, Eugenia ; Mondello, Isabella ; Visentin, Stefano ; Tormena, Francesca. / Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome : Study protocol for a randomized controlled trial. In: Trials. 2016 ; Vol. 17, No. 1.
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abstract = "Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 {\%}. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an {"}optimal{"} functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. Methods/design: In this study, 206 spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge. Trial registration: ClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015.",
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month = "8",
day = "18",
doi = "10.1186/s13063-016-1498-7",
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TY - JOUR

T1 - Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome

T2 - Study protocol for a randomized controlled trial

AU - Vento, Giovanni

AU - Pastorino, Roberta

AU - Boni, Luca

AU - Cota, Francesco

AU - Carnielli, Virgilio

AU - Cools, Filip

AU - Dani, Carlo

AU - Mosca, Fabio

AU - Pillow, Jane

AU - Polglase, Graeme

AU - Tagliabue, Paolo

AU - van Kaam, Anton H.

AU - Ventura, Maria Luisa

AU - Tana, Milena

AU - Tirone, Chiara

AU - Aurilia, Claudia

AU - Lio, Alessandra

AU - Ricci, Cinzia

AU - Gambacorta, Alessandro

AU - Consigli, Chiara

AU - D'Onofrio, Danila

AU - Gizzi, Camilla

AU - Massenzi, Luca

AU - Cardilli, Viviana

AU - Casati, Alessandra

AU - Bottino, Roberto

AU - Pontiggia, Federica

AU - Ciarmoli, Elena

AU - Martinelli, Stefano

AU - Ilardi, Laura

AU - Colnaghi, Mariarosa

AU - Matassa, Piero Giuseppe

AU - Vendettuoli, Valentina

AU - Villani, Paolo

AU - Fusco, Francesca

AU - Gazzolo, Diego

AU - Ricotti, Alberto

AU - Ferrero, Federica

AU - Stasi, Ilaria

AU - Magaldi, Rosario

AU - Maffei, Gianfranco

AU - Presta, Giuseppe

AU - Perniola, Roberto

AU - Messina, Francesco

AU - Montesano, Giovanna

AU - Poggi, Chiara

AU - Giordano, Lucio

AU - Roma, Enza

AU - Grassia, Carolina

AU - Ausanio, Gaetano

AU - Sandri, Fabrizio

AU - Mescoli, Giovanna

AU - Giura, Francesco

AU - Garani, Giampaolo

AU - Solinas, Agostina

AU - Lucente, Maria

AU - Nigro, Gabriella

AU - Del Vecchio, Antonello

AU - Petrillo, Flavia

AU - Orfeo, Luigi

AU - Grappone, Lidia

AU - Quartulli, Lorenzo

AU - Scorrano, Antonio

AU - Messner, Hubert

AU - Staffler, Alex

AU - Gargano, Giancarlo

AU - Balestri, Eleonora

AU - Nobile, Stefano

AU - Cacace, Caterina

AU - Meli, Valerio

AU - Dallaglio, Sara

AU - Pasqua, Betta

AU - Mattia, Loretta

AU - Gitto, Eloisa

AU - Vitaliti, Marcello

AU - Re, Maria Paola

AU - Vedovato, Stefania

AU - Grison, Alessandra

AU - Berardi, Alberto

AU - Torcetta, Francesco

AU - Guidotti, Isotta

AU - di Fabio, Sandra

AU - Maranella, Eugenia

AU - Mondello, Isabella

AU - Visentin, Stefano

AU - Tormena, Francesca

PY - 2016/8/18

Y1 - 2016/8/18

N2 - Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. Methods/design: In this study, 206 spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge. Trial registration: ClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015.

AB - Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. Methods/design: In this study, 206 spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge. Trial registration: ClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015.

KW - HFOV

KW - INSURE

KW - Lung recruitment

KW - Preterm infants

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U2 - 10.1186/s13063-016-1498-7

DO - 10.1186/s13063-016-1498-7

M3 - Article

AN - SCOPUS:84982231207

VL - 17

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 414

ER -