Corresponding Author: Theresa M. Frey, MD, Division of Emergency Medicine, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children’s Hospital Medical Center, 3333 Burnet Ave, MLC 2008, Cincinnati, OH 45229-3026 (theresa.frey@cchmc.org).
Accepted for Publication: October 24, 2018.
Published Online: December 28, 2018. doi:10.1001/jamapediatrics.2018.4582
Author Contributions: Drs Frey and Mittiga had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Frey, Florin, Barrett, Mittiga.
Acquisition, analysis, or interpretation of data: Frey, Florin, N. Zhang, Y. Zhang, Mittiga.
Drafting of the manuscript: Frey, Y. Zhang, Mittiga.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: N. Zhang, Y. Zhang, Mittiga.
Obtained funding: Frey.
Administrative, technical, or material support: Frey, Barrett, Mittiga.
Supervision: Frey, Florin, N. Zhang, Mittiga.
Conflict of Interest Disclosures: Dr Frey reports grants from the American Academy of Pediatrics during the conduct of the study. No other disclosures were reported.
Funding/Support: This work was supported by funding from the Division of Emergency Medicine at Cincinnati Children’s Hospital Medical Center, where the trial was completed, and by American Academy of Pediatrics Section on Emergency Medicine through the 2016 Ken Graff Young Investigator Award.
Role of the Funder/Sponsor: The funders 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.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We acknowledge Jenna Dyas, BS, Cincinnati Children’s Hospital Medical Center, and Nicole Herron, BA, Cincinnati Children’s Hospital Medical Center, who coordinated and supervised data collection; Mary Frey, MSN, CPN, RN, CNL, CPEN, Cincinnati Children’s Hospital Medical Center, who provided access to all patient video recordings (data acquisition); Scott Reeves, MD, University of Cincinnati College of Medicine and Cincinnati Children’s Hospital Medical Center, who served as the medical monitor, and therefore, was responsible for all safety monitoring; the Clinical Research Coordinator team, physicians, nurses, medics, patient care assistants, and child life specialists of the Division of Emergency Medicine at Cincinnati Children’s Hospital Medical Center who assisted with study enrollment; the Office of Clinical and Translational Research who assisted with US Food and Drug Administration correspondence and provided interim monitoring visits throughout the study; and all the patients and families who participated in the PRIME study. No individuals received compensation for their work outside of their salary.
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