Accepted for Publication: January 16, 2011.
Published Online: April 4, 2011. doi:10.1001/archpediatrics.2011.43
Author Contributions: Dr Jacobs had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Jacobs, Morley, Inder, Stewart, and Doyle. Acquisition of data: Jacobs, Stewart, McNamara, Wright, Kirpalani, and Darlow. Analysis and interpretation of data: Jacobs, Inder, Smith, McNamara, Wright, Kirpalani, Darlow, and Doyle. Drafting of the manuscript: Jacobs, Inder, Smith, McNamara, Wright, and Kirpalani. Critical revision of the manuscript for important intellectual content: Jacobs, Morley, Inder, Stewart, McNamara, Wright, Kirpalani, Darlow, and Doyle. Statistical analysis: Smith. Obtained funding: Jacobs, Morley, Inder, and Doyle. Administrative, technical, and material support: Stewart, McNamara, Wright, Kirpalani, Darlow, and Doyle. Study supervision: Inder, McNamara, Wright, and Kirpalani.
Financial Disclosure: None reported.
Funding/Support: This study was supported by project grant 216725 from the Australian National Health and Medical Research Council and by the Royal Women's Hospital Foundation.
Role of the Sponsor: The funding organizations had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Online-Only Material: This article is featured in the Archives Journal Club. Go here to download teaching PowerPoint slides.
Additional Contributions: We thank the 221 babies and their families who participated and made this trial possible. We also thank Brenda Argus, RN (research assistant), Shelley Lavery, RN (study coordinator from 2002 to 2006), and Merilyn Bear, RN (study coordinator from 2006 to 2009), and the staff of the Newborn Emergency Transport Service (Victoria) for their assistance.
Members of the Infant Cooling Evaluation (ICE) Collaboration
ICE Steering Group
S. E. Jacobs (principal investigator), C. J. Morley (chief investigator), T. E. Inder (chief investigator), M. J. Stewart (chief investigator), and L. W. Doyle (chief investigator).
Data Monitoring Committee
M. Thoresen (Chair), Department of Clinical Science, University of Bristol, St. Michael's Hospital, Bristol, England; J. Lumley, Mother and Child Health Research, La Trobe University, Melbourne, Australia; and D. J. Henderson-Smart, NSW Centre for Perinatal Health Services Research, Queen Elizabeth II Research Institute, Sydney, Australia.
K. R. Smith, Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne.
Participating Hospitals and Investigators (Number of Subjects Recruited)
S. E. Jacobs, C. J. Morley, and L.W. Doyle, Royal Women's Hospital (n = 35); M. J. Stewart, Royal Children's Hospital (n = 13); and D. Casalaz and G. Opie, Mercy Hospital for Women (n = 3) (all in Melbourne); I. M. R. Wright, John Hunter Children's Hospital (n = 25); H. Jeffrey, Royal Prince Alfred Hospital (n = 14); M. Kluckow, Royal North Shore Hospital (n = 3); J. Stack, Liverpool Hospital (n = 1); J. L. Oei and K. Lui, Royal Hospital for Women (n = 1); M. Rochefort and W. Tarnow-Mordi, Westmead Hospital (n = 0); N. Badawi, The Children's Hospital at Westmead (n = 0); and A. Berry, NSW Neonatal and Paediatric Emergency Transport Service (number of subjects is not applicable) (all in New South Wales, Australia); J. Sokol and S. Rao, King Edward and Princess Margaret Hospitals, Western Australia (n = 27); B. Headley and R. Haslam, Women's and Children's Hospital, South Australia (n = 5); Z. Kecskes, The Canberra Hospital, Australian Capital Territory, Australia (n = 1); L. Cooke, Mater Mother's Hospital (n = 3), and P. Colditz, Royal Brisbane and Women's Hospital (n = 1) (both in Queensland, Australia); T. DePaoli, Royal Hobart Hospital, Tasmania, Australia (n = 0); N. Austin and B. A. Darlow, Christchurch Women's Hospital, University of Otago, Christchurch, New Zealand (n = 12); P. Weston, Waikato Hospital, Hamilton, New Zealand (n = 10); R. Broadbent, Dunedin Hospital, Otago, New Zealand (n = 2); H. Whyte and P. J. McNamara, Hospital for Sick Children, Toronto, Ontario, Canada (n = 33); H. M. Kirpalani, McMaster Medical Centre, Hamilton, Ontario, Canada (n = 19); A. Solimano, Children's and Women's Health Centre of British Columbia, Vancouver, Canada (n = 8); P. Karna, Sparrow Hospital, Lansing, Michigan (n = 2); A. Mathur and T. E. Inder, St Louis Children's Hospital, St Louis, Missouri (n = 3); D. Sobel, Barbara Bush Children's Hospital, Portland, Maine (n = 0); D. Rosenblum, St Luke's Hospital, Cedar Rapids, Iowa (n = 0); N. Desai, University of Kentucky, Lexington (n = 0); K. Schroeter, Vermont Children's Hospital, Burlington (n = 0).