Study concept and design: Feenstra, Geller, Melbye.
Acquisition of data: Feenstra, Geller, Romitti, Körberg, Bedell, Krogh, Svenningsson, Caggana, Nordenskjöld, Mills, Murray.
Analysis and interpretation of data: Feenstra, Geller, Carstensen, Romitti, Körberg, Fan, Murray, Melbye.
Drafting of the manuscript: Feenstra, Geller, Melbye.
Critical revision of the manuscript for important intellectual content: Feenstra, Geller, Carstensen, Romitti, Körberg, Bedell, Krogh, Fan, Svenningsson, Caggana, Nordenskjöld, Mills, Murray, Melbye.
Statistical analysis: Feenstra, Geller, Carstensen, Fan.
Obtained funding: Feenstra, Geller, Romitti, Nordenskjöld, Mills, Murray, Melbye.
Study supervision: Feenstra, Melbye.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Feenstra, Mr Geller, and Dr Melbye reported being listed on the priority patent application filed by Statens Serum Institut at the Danish Patent and Trademark Office on the use of genetic profiling to identify newborns at risk of IHPS, which contains subject matter drawn from the work also published here. No other conflicts were reported.
Funding/Support: The study was supported by grants from the Lundbeck Foundation (R34-A3931), the Novo Nordisk Foundation, the Danish Medical Research Council (271-06-0628), the Swedish Research Council, the Centers for Disease Control and Prevention (5U01DD000492), and the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The GWAS data for the control samples were generated for our study of preterm birth within the GENEVA consortium with funding provided through the National Institutes of Health Genes, Environment, and Health Initiative (U01HG004423). Dr Feenstra is supported by an Oak Foundation Fellowship.
Role of the Sponsor: The funding agency had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentation: We have submitted an abstract based on results from this study to the American Society of Human Genetics meeting; October 22-26, 2013.
Additional Contributions: We thank the participants and their families, as well as the staff involved in recruiting and managing the study groups for their contributions to this study. The participants received no compensation for their contribution; the staff did not receive compensation besides their salaries.