Accepted for Publication: September 2, 2013.
Published Online: December 9, 2013. doi:10.1001/jamapediatrics.2013.4208.
Study concept and design: Laughon, Avant, Clark, Smith, Rodriguez.
Acquisition of data: Laughon, Avant, Tripathi, Clark, Smith.
Analysis and interpretation of data: Laughon, Avant, Hornik, Cohen-Wolkowiez, Smith, Rodriguez.
Drafting of the manuscript: Laughon, Avant, Clark, Rodriguez.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Laughon, Avant, Hornik.
Administrative, technical, or material support: Laughon, Avant, Tripathi, Cohen-Wolkowiez, Smith, Rodriguez.
Study supervision: Laughon, Cohen-Wolkowiez, Clark, Rodriguez.
Conflict of Interest Disclosures: Dr Cohen-Wolkowiez has received support for research from Pfizer, Cempra, Diomorph, Aptiv Solutions, GlaxoSmithKline, Janssen Research and Development, Special Products Ltd, Tetraphase Pharmaceuticals, and The Medicines Company for neonatal and pediatric drug development. Dr Smith receives research support from Astellas Pharma US, Cubist Pharmaceuticals, Johnson & Johnson, Pfizer, Pangen Biosystems Inc, and CV Therapeutics Inc for neonatal and pediatric drug development. No other disclosures were reported.
Funding/Support: This study used Clinical and Translational Science Award biostatistical services through the Division of Pediatric Quantitative Sciences (National Institutes of Health grant 5UL-1RR024128-01). Dr Laughon receives support from the US government for his work in pediatric and neonatal clinical pharmacology (government contract HHSN267200700051C, principal investigator D. K. Benjamin, Jr, MD, PhD, MPH, under the Best Pharmaceuticals for Children Act) and from Eunice Kennedy Shriver National Institute of Child Health and Human Development grant 1K23HL092225-01. Dr Cohen-Wolkowiez receives support for research from National Institutes of Health grant 1K23HD064814 and the nonprofit organization Thrasher Research Fund (www.thrasherresearch.org). Dr Smith receives salary support for research from the National Institutes of Health and the US Department of Health and Human Services (Eunice Kennedy Shriver National Institute of Child Health and Human Development grant 1K23HD060040-01, Department of Health and Human Services grant 1R18AE000028-01, and government contract HHSN267200700051C).
Disclaimer: The views expressed in this article are those of the authors. No official endorsement by the US FDA is provided or should be inferred.
Role of the Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Dianne Murphy, MD, at the FDA for advice, review, and editing of the manuscript.