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

Author

Davidson, Andrew J, Disma, Nicola, de Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, von Ungern Sternberg, Britta S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Frawley, Geoff, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, and McCann, Mary Ellen

Published
2016
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3. Mental health impacts of the COVID-19 pandemic on children and adolescents with chronic health conditions

Author

Crowe, Louise M, primary, Clarke, Cathriona, additional, Hearps, Stephen, additional, Pugh, Remy, additional, Kilpatrick, Nicky, additional, Branson, Emma, additional, Payne, Jonathan M, additional, Haebich, Kristina M, additional, McCloughan, Natalie, additional, Kintakas, Christopher, additional, Charles, Genevieve, additional, Trajanovska, Misel, additional, Hsieh, Ivy, additional, Hartmann, Penelope L, additional, King, Sebastian, additional, Anderson, Nicholas, additional, and Anderson, Vicki A, additional

Published
2021
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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, 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

5. 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

7. 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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8. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy

Author

Davidson, Andrew, Disma, Nicole, De Graaff, Jurgen C., Withington, Davinia E., Dorris, Liam, Bell, Graham T., Stargatt, Robyn, Bellinger, David C., Schuster, Tibor, Arnup, Sarah, Hardy, Pollyanna, Hunt, Rod, Takagi, Michael, Giribaldi, Gaia, Hartmann, Penelope, Salvo, Ida, Morton, Neil Stuart, von Ungern-Sternberg, Britta S., Locatelli, Bruno Guido, Wilton, Niall C. T., Lynn, Anne Merie, Thomas, Joss John, Polaner, David M., Bagshaw, Oliver N. T., Szmuk, Peter, Absalom, Anthony R., Frawley, Geoff P., Berde, Charles B., Ormond, Gillian D., Marmor, Jacki, and McCann, Mary Ellen

Abstract

Background Preclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial.Methods In this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks’ gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevofl urane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov, number NCT00756600.Findings Between Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the as-per-protocol analysis, the cognitive composite score (mean [SD]) was 98·6 (14·2) in the awake-regional group and 98·2 (14·7) in the general anaesthesia group. There was equivalence in mean between groups (awake-regional minus general anaesthesia 0·169, 95% CI –2·30 to 2·64). The median duration of anaesthesia in the general anaesthesia group was 54 min.Interpretation For this secondary outcome, we found no evidence that just less than 1 h of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at 2 years of age compared with awake-regional anaesthesia.Funding Australia National Health and Medical Research Council (NHMRC), Health Technologies Assessment-National Institute for Health Research UK, National Institutes of Health, Food and Drug Administration, Australian and New Zealand College of Anaesthetists, Murdoch Childrens Research Institute, Canadian Institute of Health Research, Canadian Anesthesiologists’ Society, Pfizer Canada, Italian Ministry of Heath, Fonds NutsOhra, and UK Clinical Research Network (UKCRN).

Published
2016

9. Apnea after awake regional and general anesthesia in infants: The general anesthesia compared to spinal anesthesia study-comparing apnea and neurodevelopmental outcomes, a randomized controlled trial

Author

Davidson, Andrew J., Morton, Neil S., Arnup, Sarah J., de Graaff, Jurgen C., Disma, Nicola, Withington, Davinia E., Frawley, Geoff, Hunt, Rodney W., Hardy, Pollyanna, Khotcholava, Magda, von Ungern Sternberg, Britta S., Wilton, Niall, Tuo, Pietro, Salvo, Ida, Ormond, Gillian D., Stargatt, Robyn, Locatelli, Bruno Guido, McCann, Mary Ellen, General Anesthesia compared to Spinal anesthesia (GAS) Consortium, and Hartmann, Penelope

Abstract

Background: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Methods: Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation. The primary outcome of this analysis was any observed apnea up to 12 h postoperatively. Apnea assessment was unblinded. Results: Three hundred sixty-three patients were assigned to RA and 359 to GA. Overall, the incidence of apnea (0 to 12 h) was similar between arms (3% in RA and 4% in GA arms; odds ratio [OR], 0.63; 95% CI, 0.31 to 1.30, P = 0.2133); however, the incidence of early apnea (0 to 30 min) was lower in the RA arm (1 vs. 3%; OR, 0.20; 95% CI, 0.05 to 0.91; P = 0.0367). The incidence of late apnea (30 min to 12 h) was 2% in both RA and GA arms (OR, 1.17; 95% CI, 0.41 to 3.33; P = 0.7688). The strongest predictor of apnea was prematurity (OR, 21.87; 95% CI, 4.38 to 109.24), and 96% of infants with apnea were premature. Conclusions: RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period. Cardiorespiratory monitoring should be used for all ex-premature infants.

Published
2015

10. Predictors of failure of awake regional anesthesia for neonatal hernia repair : Data from the General Anesthesia Compared to Spinal Anesthesia Study - Comparing apnea and neurodevelopmental outcomes

Author

Frawley, Geoff, Bell, Graham, Disma, Nicola, Withington, Davinia E., de Graaff, Jurgen C., Morton, Neil S., McCann, Mary Ellen, Arnup, Sarah J., Bagshaw, Oliver, Wolfler, Andrea, Bellinger, David, Davidson, Andrew J., the General Anesthesia compared to Spinal anesthesia (GAS) Consortium, and Hartmann, Penelope

Abstract

Background: Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants. The aim of the study is to describe success and failure rates of RA and report factors associated with failure. Methods: This was a nested cohort study within a prospective, randomized, controlled, observer-blind, equivalence trial. Seven hundred twenty-two infants 60 weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA (spinal, caudal epidural, or combined spinal caudal anesthetic) or GA with sevoflurane. The data of 339 infants, where spinal or combined spinal caudal anesthetic was attempted, were analyzed. Possible predictors of failure were assessed including patient factors, technique, experience of site and anesthetist, and type of local anesthetic. Results: RA was sufficient for the completion of surgery in 83.2% of patients. Spinal anesthesia was successful in 86.9% of cases and combined spinal caudal anesthetic in 76.1%. Thirty-four patients required conversion to GA, and an additional 23 patients (6.8%) required brief sedation. Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure (odds ratio = 2.46). Conclusions: The failure rate of spinal anesthesia was low. Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone.

Published
2015

11. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial

Author

Development and Treatment of Psychosocial Problems, Davidson, Andrew J, Disma, Nicola, De Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, Von Ungern Sternberg, Britta S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Frawley, Geoff, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, Mccann, Mary Ellen, Development and Treatment of Psychosocial Problems, Davidson, Andrew J, Disma, Nicola, De Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, Von Ungern Sternberg, Britta S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Frawley, Geoff, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, and Mccann, Mary Ellen

Published
2016

12. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.

Author

Davidson, AJ, von Ungern Sternberg, BS, Frawley, G, Disma, Nicola, de Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, McCann, Mary Ellen, Davidson, AJ, von Ungern Sternberg, BS, Frawley, G, Disma, Nicola, de Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, and McCann, Mary Ellen

Abstract

Preclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial. In this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks' gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevoflurane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov, number NCT00756600. Between Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the as

Published
2016

13. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial

Author

Medische staf Anesthesiologie, Brain, Davidson, Andrew J, Disma, Nicola, de Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, von Ungern Sternberg, Britta S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Frawley, Geoff, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, McCann, Mary Ellen, GAS consortium, Medische staf Anesthesiologie, Brain, Davidson, Andrew J, Disma, Nicola, de Graaff, Jurgen C, Withington, Davinia E, Dorris, Liam, Bell, Graham, Stargatt, Robyn, Bellinger, David C, Schuster, Tibor, Arnup, Sarah J, Hardy, Pollyanna, Hunt, Rodney W, Takagi, Michael J, Giribaldi, Gaia, Hartmann, Penelope L, Salvo, Ida, Morton, Neil S, von Ungern Sternberg, Britta S, Locatelli, Bruno Guido, Wilton, Niall, Lynn, Anne, Thomas, Joss J, Polaner, David, Bagshaw, Oliver, Szmuk, Peter, Absalom, Anthony R, Frawley, Geoff, Berde, Charles, Ormond, Gillian D, Marmor, Jacki, McCann, Mary Ellen, and GAS consortium

Published
2016

14. Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Author

Medische staf Anesthesiologie, Circulatory Health, Brain, Davidson, Andrew J., Morton, Neil S., Arnup, Sarah J., De Graaff, Jurgen C., Disma, Nicola, Withington, Davinia E., Frawley, Geoff, Hunt, Rodney W., Hardy, Pollyanna, Khotcholava, Magda, Von Ungern Sternberg, Britta S., Wilton, Niall, Tuo, Pietro, Salvo, Ida, Ormond, Gillian, Stargatt, Robyn, Locatelli, Bruno Guido, McCann, Mary Ellen, Lee, Katherine, Sheppard, Suzette, Hartmann, Penelope, Ragg, Philip, Backstrom, Marie, Costi, David, Von Ungern-Sternberg, Britta S., Knottenbelt, Graham, Montobbio, Giovanni, Mameli, Leila, Giribaldi, Gaia, Prato, Alessio Pini, Mattioli, Girolamo, Wolfler, Andrea, Izzo, Francesca, Sonzogni, Valter, Van Gool, Jose T D G, Numan, Sandra C., Kalkman, Cor J., Hagenaars, J. H M, Absalom, Anthony R., Hoekstra, Frouckje M., Volkers, Martin J., Furue, Koto, Gaudreault, Josee, Berde, Charles, Soriano, Sulpicio, Young, Vanessa, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph P., Bellinger, David, Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Meuller, Martin, Haret, Denisa, Szmuk, Peter, Steiner, Jeffery, Kravitz, Brian, Suresh, Santhanam, Hays, Stephen R., Taenzer, Andreas H., Maxwell, Lynne G., Williams, Robert K., Bell, Graham T., Dorris, Liam, Adey, Claire, Bagshaw, Oliver, Chisakuta, Anthony, Eissa, Ayman, Stoddart, Peter, Davis, Annette, Myles, Paul, Wolf, Andy, McIntosh, Neil, Carlin, John, Leslie, Kate, De Lima, Jonathan, Hammer, Greg, Field, David, Gebski, Val, Tibboel, Dick, Medische staf Anesthesiologie, Circulatory Health, Brain, Davidson, Andrew J., Morton, Neil S., Arnup, Sarah J., De Graaff, Jurgen C., Disma, Nicola, Withington, Davinia E., Frawley, Geoff, Hunt, Rodney W., Hardy, Pollyanna, Khotcholava, Magda, Von Ungern Sternberg, Britta S., Wilton, Niall, Tuo, Pietro, Salvo, Ida, Ormond, Gillian, Stargatt, Robyn, Locatelli, Bruno Guido, McCann, Mary Ellen, Lee, Katherine, Sheppard, Suzette, Hartmann, Penelope, Ragg, Philip, Backstrom, Marie, Costi, David, Von Ungern-Sternberg, Britta S., Knottenbelt, Graham, Montobbio, Giovanni, Mameli, Leila, Giribaldi, Gaia, Prato, Alessio Pini, Mattioli, Girolamo, Wolfler, Andrea, Izzo, Francesca, Sonzogni, Valter, Van Gool, Jose T D G, Numan, Sandra C., Kalkman, Cor J., Hagenaars, J. H M, Absalom, Anthony R., Hoekstra, Frouckje M., Volkers, Martin J., Furue, Koto, Gaudreault, Josee, Berde, Charles, Soriano, Sulpicio, Young, Vanessa, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph P., Bellinger, David, Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Meuller, Martin, Haret, Denisa, Szmuk, Peter, Steiner, Jeffery, Kravitz, Brian, Suresh, Santhanam, Hays, Stephen R., Taenzer, Andreas H., Maxwell, Lynne G., Williams, Robert K., Bell, Graham T., Dorris, Liam, Adey, Claire, Bagshaw, Oliver, Chisakuta, Anthony, Eissa, Ayman, Stoddart, Peter, Davis, Annette, Myles, Paul, Wolf, Andy, McIntosh, Neil, Carlin, John, Leslie, Kate, De Lima, Jonathan, Hammer, Greg, Field, David, Gebski, Val, and Tibboel, Dick

Published
2015

15. 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

Ellen McCann, Mary, 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 C., Hartmann, Penelope L., Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, von Ungern Sternberg, Britta S., Lynn, Anne, and Wilton, Niall

Subjects
*NEUROTOXICOLOGY, *ANESTHESIA, *NEURODEVELOPMENTAL treatment, *NEUROLOGICAL intensive care, *ANESTHETICS, *CHILD development, *COMPARATIVE studies, *INGUINAL hernia, *INTELLIGENCE tests, *INTERNATIONAL relations, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *RESEARCH funding, *EVALUATION research, *RANDOMIZED controlled trials, *GENERAL anesthesia
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 Feb 9, 2007, and Jan 31, 2013, 4023 infants were screened and 722 were randomly allocated: 363 (50%) to the awake-regional anaesthesia group and 359 (50%) to the general anaesthesia group. There were 74 protocol violations in the awake-regional anaesthesia group and two in the general anaesthesia group. Primary outcome data for the per-protocol analysis were obtained from 205 children in the awake-regional anaesthesia group and 242 in the general anaesthesia group. The median duration of general anaesthesia was 54 min (IQR 41-70). The mean FSIQ score was 99·08 (SD 18·35) in the awake-regional anaesthesia group and 98·97 (19·66) in the general anaesthesia group, with a difference in means (awake-regional anaesthesia minus general anaesthesia) of 0·23 (95% CI -2·59 to 3·06), providing strong evidence of equivalence. The results of the intention-to-treat analysis were similar to those of the per-protocol analysis.Interpretation: Slightly less than 1 h of general anaesthesia in early infancy does not alter neurodevelopmental outcome at age 5 years compared with awake-regional anaesthesia in a predominantly male study population.Funding: US National Institutes of Health, US Food and Drug Administration, Thrasher Research Fund, Australian National Health and Medical Research Council, Health Technologies Assessment-National Institute for Health Research (UK), Australian and New Zealand College of Anaesthetists, Murdoch Children's Research Institute, Canadian Institutes of Health Research, Canadian Anesthesiologists Society, Pfizer Canada, Italian Ministry of Health, Fonds NutsOhra, UK Clinical Research Network, Perth Children's Hospital Foundation, the Stan Perron Charitable Trust, and the Callahan Estate. [ABSTRACT FROM AUTHOR]

Published
2019
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