Academic Journal
Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial
| العنوان: | Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial |
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| المؤلفون: | Davidson, AJ, Disma, N, de Graaff, JC, Withington, DE, Dorris, L, Bell, G, Stargatt, R, Bellinger, DC, Schuster, T, Arnup, SJ, Hardy, P, Hunt, RW, Takagi, MJ, Giribaldi, G, Hartmann, PL, Salvo, I, Morton, NS, Sternberg, BSVU, Locatelli, BG, Wilton, N, Lynn, A, Thomas, JJ, Polaner, D, Bagshaw, O, Szmuk, P, Absalom, AR, Frawley, G, Berde, C, Ormond, GD, Marmor, J, McCann, ME |
| بيانات النشر: | ELSEVIER SCIENCE INC |
| سنة النشر: | 2016 |
| المجموعة: | The University of Melbourne: Digital Repository |
| الوصف: | 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 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. 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0140-6736 1474-547X |
| Relation: | pii: S0140-6736(15)00608-X; Davidson, A. J., Disma, N., de Graaff, J. C., Withington, D. E., Dorris, L., Bell, G., Stargatt, R., Bellinger, D. C., Schuster, T., Arnup, S. J., Hardy, P., Hunt, R. W., Takagi, M. J., Giribaldi, G., Hartmann, P. L., Salvo, I., Morton, N. S., Sternberg, B. S. V. U., Locatelli, B. G. ,. McCann, M. E. (2016). Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. LANCET, 387 (10015), pp.239-250. https://doi.org/10.1016/S0140-6736(15)00608-X.; http://hdl.handle.net/11343/261903 |
| الاتاحة: | http://hdl.handle.net/11343/261903 |
| Rights: | CC BY-NC-ND ; https://creativecommons.org/licenses/by-nc-nd/4.0 |
| رقم الانضمام: | edsbas.CF44FFB9 |
| قاعدة البيانات: | BASE |
| تدمد: | 01406736 1474547X |
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