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1. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

Author

Davidson, Andrew J, Frawley, Geoff, Hardy, Pollyanna, Arnup, Sarah, Grobler, Anneke, Lee, Katherine, Hunt, Rod W, Stargatt, Robyn, Sheppard, Suzette J, Ormond, Gillian D, Hartmann, Penelope L, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, von Ungern-Sternberg, Britta, Wilton, Niall C, Knottenbelt, Graham, Withington, Davinia, Furue, Koto, Gagnon, Hélène, Disma, Nicola, Mameli, Leila, Giribaldi, Gaia, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Izzo, Francesca, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, de Graaff, Jurgen C, van der Werff, Desiree BM, van Gool, Jose TDG, van Loon, Kim, Kalkman, Cor J, van Baar, Anneloes L, Absalom, Anthony R, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Bell, Graham, Dorris, Liam, Morton, Neil S, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, McCann, Mary Ellen, Berde, Charles, Soriano, Sulpicio, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Bellinger, David, Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Mueller, Martin, Haret, Denisa, Szmuk, Peter, Steiner, Jeffrey, Kravitz, Brian, Farrow-Gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, Williams, Robert, Hunt, Rodney W, Bellinger, David C, von Ungern Sternberg, Britta S, Wilton, Niall, Polaner, David M, and Morton, Neil

Published
2019
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2. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

Author

Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, Williams, Robert, Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, and Williams, Robert

Abstract

Background In laboratory animals, exposure to most general anaesthetics leads to neurotoxicity manifested by neuronal cell death and abnormal behaviour and cognition. Some large human cohort studies have shown an association between general anaesthesia at a young age and subsequent neurodevelopmental deficits, but these studies are prone to bias. Others have found no evidence for an association. We aimed to establish whether general anaesthesia in early infancy affects neurodevelopmental outcomes. Methods In this international, assessor-masked, equivalence, randomised, controlled trial conducted at 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand, we recruited infants of less than 60 weeks' postmenstrual age who were born at more than 26 weeks' gestation and were undergoing inguinal herniorrhaphy, without previous exposure to general anaesthesia or risk factors for neurological injury. Patients were randomly assigned (1:1) by use of a web-based randomisation service to receive either awake-regional anaesthetic or sevoflurane-based general anaesthetic. Anaesthetists were aware of group allocation, but individuals administering the neurodevelopmental assessments were not. Parents were informed of their infants group allocation upon request, but were told to mask this information from assessors. The primary outcome measure was full-scale intelligence quotient (FSIQ) on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III), at 5 years of age. The primary analysis was done on a per-protocol basis, adjusted for gestational age at birth and country, with multiple imputation used to account for missing data. An intention-to-treat analysis was also done. A difference in means of 5 points was predefined as the clinical equivalence margin. This completed trial is registered with ANZCTR, number ACTRN12606000441516, and ClinicalTrials.gov, number NCT00756600. Findings Between F

Published
2019

3. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

Author

Leerstoel Baar, Development and Treatment of Psychosocial Problems, Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, Williams, Robert, Leerstoel Baar, Development and Treatment of Psychosocial Problems, Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, and Williams, Robert

Published
2019

4. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

Author

McCann, Mary Ellen, primary, de Graaff, Jurgen C, additional, Dorris, Liam, additional, Disma, Nicola, additional, Withington, Davinia, additional, Bell, Graham, additional, Grobler, Anneke, additional, Stargatt, Robyn, additional, Hunt, Rodney W, additional, Sheppard, Suzette J, additional, Marmor, Jacki, additional, Giribaldi, Gaia, additional, Bellinger, David C, additional, Hartmann, Penelope L, additional, Hardy, Pollyanna, additional, Frawley, Geoff, additional, Izzo, Francesca, additional, von Ungern Sternberg, Britta S, additional, Lynn, Anne, additional, Wilton, Niall, additional, Mueller, Martin, additional, Polaner, David M, additional, Absalom, Anthony R, additional, Szmuk, Peter, additional, Morton, Neil, additional, Berde, Charles, additional, Soriano, Sulpicio, additional, Davidson, Andrew J, additional, Arnup, Sarah, additional, Lee, Katherine, additional, Hunt, Rod W, additional, Ormond, Gillian D, additional, Takagi, Michael J, additional, Taylor, Kaitlyn, additional, Malarbi, Stephanie, additional, Doyle, Melissa, additional, Ragg, Philip, additional, Costi, David, additional, von Ungern-Sternberg, Britta, additional, Wilton, Niall C, additional, Knottenbelt, Graham, additional, Furue, Koto, additional, Gagnon, Hélène, additional, Mameli, Leila, additional, Pini Prato, Alessio, additional, Mattioli, Girolamo, additional, Wolfler, Andrea, additional, Bova, Stefania M, additional, Krachmalnicoff, Arianna, additional, Guuva, Claudia, additional, van der Werff, Desiree BM, additional, van Gool, Jose TDG, additional, van Loon, Kim, additional, Kalkman, Cor J, additional, van Baar, Anneloes L, additional, Hoekstra, Frouckje M, additional, Volkers, Martin, additional, Oostra, Martine, additional, Morton, Neil S, additional, Pownall, Jaycee, additional, Waldman, Jack, additional, Hind, Ruth, additional, Symonds, Joseph D, additional, Bagshaw, Oliver, additional, McCann, Mary Ellen, additional, Sethna, Navil, additional, Kovatsis, Pete, additional, Cravero, Joseph, additional, Bellinger, David, additional, Ivanova, Iskra, additional, Hunyady, Agnes, additional, Verma, Shilpa, additional, Polaner, David, additional, Thomas, Joss, additional, Haret, Denisa, additional, Steiner, Jeffrey, additional, Kravitz, Brian, additional, Farrow-Gillespie, Alan, additional, Suresh, Santhanam, additional, Hays, Stephen, additional, Taenzer, Andreas, additional, Maxwell, Lynne, additional, and Williams, Robert, additional

Published
2019
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