Journal article

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

AJ Davidson, N Disma, JC de Graaff, DE Withington, L Dorris, G Bell, R Stargatt, DC Bellinger, T Schuster, SJ Arnup, P Hardy, RW Hunt, MJ Takagi, G Giribaldi, PL Hartmann, I Salvo, NS Morton, BS von Ungern Sternberg, BG Locatelli, N Wilton Show all

Lancet | ELSEVIER SCIENCE INC | Published : 2016

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 ..

View full abstract

Grants

Awarded by Pfizer Canada


Funding Acknowledgements

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).All hospitals and centres were generously supported by departmental funding. In addition to this funding, specific grants received for this study are as follows: Australia: The Australian National Health & Medical Research Council (Project Grants #1002906 and 491226); Australian and New Zealand College of Anaesthetists (Project Grant #11/021 and 07/012); Murdoch Childrens Research Institute; Victorian Government's Operational Infrastructure Support Program. US: National Institute of Health (Project Grant # NIH 1-R01 hD06 1136-01A1); Food and Drug Administration (Project Grant #FDA-SOL-08-SAFEKIDS-Clin 002-Project 2). Italy: Italian Ministry of Heath, Young Researchers Grant (Project Grant #167/GR-2009-1476067). Netherlands: Fonds NutsOhra grant #1305-144 and Vrienden WKZ 16.13.038. Canada: Canadian Institute of Health Research (Project Grant #MCT-98031), Canadian Anesthesiologists' Society, Pfizer Canada Inc. UK: Health Technologies Assessment-National Institute for Health Research UK (Project Grant #07/01/05). We are also grateful to the following individuals who contributed to the running of the study: Mark Fagjman (Department of Anaesthesia, Monash Medical Centre, Melbourne, VIC, Australia); Daniela Tronconi (Department of Anesthesia, Istituto Giannina Gaslini, Genoa, Italy); David C van der Zee (Department of Pediatric Surgery, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Netherlands); Jan Hulscher (Department of Surgery, University Medical Center Groningen, Groningen University, Groningen, Netherlands); Michael Rivkin (Department of Neurology, Children's Hospital Boston, Boston, MA, USA); Michelle Sadler-Greever (University of Washington, Seattle Children's Hospital, Department of Anesthesia and Pain Medicine, Seattle, WA, USA); Debra Faulk (Children's Hospital Colorado and University of Colorado School of Medicine, Department of Anesthesiology, Colorado, CO, USA); Greta Wilkening (Neurosciences Institute, Children's Hospital Colorado, CO, USA); Edward Goldson (Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, Children's Hospital Colorado, Colorado, USA). Danai Udomtecha and Sarah Titler (The University of Iowa Hospital, Department of Anesthesia, Iowa, IA, USA); Roxana Ploski and Alan Farrow-Gilespie (Children's Medical Centre Dallas, Department of Anesthesiology, University of Texas Southwestern Medical Center, Dallas and Children's Medical Center at Dallas and Outcome Research Consortium, Dallas, TX, USA); Timothy Cooper (Division of Developmental Medicine and the Center for Child Development, Monroe Carell Jr Children's Hospital at Vanderbilt, Nashville, TN, USA); Elizabeth Card (Perioperative Clinical Research Institute, Vanderbilt University Medical Center, Nashville, TN, USA); Wendy Boardman (Dartmouth-Hitchcock Medical Center, Department of Anesthesiology, NH, USA); Theodora K Goebel (Department of Anesthesiology and Critical Care Children's Hospital of Philadelphia, Philadelphia, PA, USA).