Published Online: October 17, 2012. doi:10.1001/jama.2012.12424
Author Contributions: Dr Van den Berghe had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Mesotten and Gielen and Ms Sterken contributed equally to the manuscript.
Study concept and design: Mesotten, Gielen, Sterken, Vlasselaers, Lemiere, Lagae, Vanhorebeek, Wouters, Van den Berghe.
Acquisition of data: Gielen, Sterken, Claessens, Vlasselaers, Gewillig, Eyskens.
Analysis and interpretation of data: Mesotten, Gielen, Sterken, Hermans, Van den Berghe.
Drafting of the manuscript: Mesotten, Gielen, Sterken, Van den Berghe.
Critical revision of the manuscript for important intellectual content: Mesotten, Gielen, Sterken, Claessens, Hermans, Vlasselaers, Lemiere, Lagae, Gewillig, Eyskens, Vanhorebeek, Wouters, Van den Berghe.
Statistical analysis: Mesotten, Gielen, Sterken, Hermans, Van den Berghe.
Obtained funding: Mesotten, Gielen, Vanhorebeek, Van den Berghe.
Administrative, technical, or material support: Claessens, Vlasselaers, Gewillig, Vanhorebeek, Wouters.
Study supervision: Mesotten, Lemiere, Lagae, Gewillig, Eyskens, Vanhorebeek, Van den Berghe.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Lagae reported having board membership and receiving consultancy fees and payment for lectures from Viropharma and Cyberonics, and receiving payment for lectures from Eisai and UCB. No other authors reported any disclosures.
Funding/Support: This research was fully supported by official research grants IWT/070695/TBM from the Institute for Science and Technology, Flanders, Belgium (via Catholic University of Leuven to Drs Van den Berghe, Mesotten, and Vanhorebeek); METH08/07 from the Methusalem Program of the Flemish Government (via Catholic University of Leuven to Dr Van den Berghe); from the FWO Research Foundation–Flanders, Belgium (PhD fellowship to Dr Gielen and postdoctoral fellowship to Dr Mesotten); and from the Clinical Research Fund of the Leuven University Hospital (postdoctoral fellowship to Dr Hermans).
Role of the Sponsor: The sponsors 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.
Additional Contributions: We thank all patients, healthy volunteers, and their families for enthusiastic participation in this study. Peter Stiers, MPsych, PhD and Heidi Wouters, MPsych (Department of Pediatric Neurology, Catholic University of Leuven, Leuven, Belgium), provided valuable discussions about the choice of the neurocognitive test battery; Andrea Freys and Astrid Vloemans (Department of Pediatric and Congenital Cardiology, Catholic University of Leuven, Leuven, Belgium) ensured a smooth transition from pediatric cardiology consultation to follow-up assessments; and Jenny Gielens (Department of Intensive Care Medicine, Catholic University of Leuven, Leuven, Belgium) provided secretarial help. Steffen Fieuws, MSc, PhD (Department of Biostatistics, Catholic University of Leuven, Leuven, Belgium), provided help with the multiple imputation approach. These collaborators did not receive any compensation for their contributions.