Submitted for Publication: September 20, 2013; final revision received November 8, 2013; accepted December 16, 2013.
Published Online: February 13, 2014. doi:10.1001/jamaoto.2013.6723.
Study concept and design: Bauman, McCarter, Guzzetta, Oh, Preciado, Puttgen.
Acquisition of data: Bauman, Guzzetta, Oh, Greene, Puttgen.
Analysis and interpretation of data: McCarter, Shin, Oh, Preciado, He, Greene, Puttgen
Drafting of the manuscript: Bauman, McCarter, Guzzetta, Shin, Puttgen.
Critical revision of the manuscript for important intellectual content: Bauman, McCarter, Guzzetta, Shin, Oh, Preciado, He, Greene, Puttgen.
Statistical analysis: Bauman, McCarter, Shin, He, Puttgen.
Obtained funding: Bauman.
Administrative, technical, and material support: Bauman, McCarter, Guzzetta, Oh, Preciado, Greene, Puttgen.
Study supervision: Bauman, Guzzetta, Greene, Puttgen.
Manuscript review: Guzzetta, Oh, Preciado, Greene.
Conflict of Interest Disclosures: Drs Bauman, McCarter, and Puttgen received modest salary support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, and from the National Center for Research Resources of the National Institutes of Health to complete the study. Dr Shin receives book royalties from Springer Publishing and Plural Publishing for Evidence-Based Otolaryngology and Otolaryngology Prep and Practice, respectively. No other disclosures were reported.
Funding/Support: Work for the research reported in this publication was supported by grant R21HD062959-02 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, and by grant UL1RR031988 from the National Center for Research Resources of the National Institutes of Health.
Role of the Sponsor: The financial support was used for design and conduct of the study, study medications, and collection, interpretation and analysis of the data, but the sponsors themselves 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.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Additional Contributions: The authors acknowledge the support of Ed Connor, MD, PriyaVaidyanathan, MD, and Marlene Lee, RN, who served on the DSMB; Jennifer Gode, RN, who served as clinical nurse coordinator for a portion of the study; Margie Brown, who assisted with manuscript preparation; and the study participants and their parents.
Correction: This article was corrected on March 11, 2014, to fix a value in Figure 1.