Study concept and design: Chamberlain, Holsti, Mahajan, Brown, Baren.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Chamberlain, Brown, Grubenhoff, Zemek.
Critical revision of the manuscript for important intellectual content: Chamberlain, Okada, Holsti, Mahajan, Brown, Vance, Gonzalez, Lichenstein, Stanley, Brousseau, Zemek, Johnson, Clemons, Baren.
Statistical analysis: Clemons.
Obtained funding: Chamberlain, Brown.
Administrative, technical, or material support: Okada, Holsti, Vance, Gonzalez, Stanley, Brousseau, Grubenhoff, Baren.
Study supervision: Chamberlain, Okada, Holsti, Mahajan, Brown, Baren.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Okada reported having received grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development/Children’s National Health Center during the conduct of the study. Drs Mahajan, Lichenstein, and Grubenhoff reported having received grants from the National Institutes of Health during the conduct of the study. Dr Brousseau reported consulting for Mast Therapeutics. No other disclosures were reported.
Funding/Support: This study was funded by grant HHSN275201100017C from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The Pediatric Emergency Care Applied Research Network (PECARN) is supported by cooperative agreements U03MC00001, U03MC00003, U03MC00006, U03MC00007, and U03MC00008 from the Emergency Medical Services for Children (EMSC) program of the Maternal and Child Health Bureau (MCHB), Health Resources and Services Administration, Department of Health and Human Services. The Best Pharmaceuticals for Children Act Data Coordinating Center for this study was the EMMES Corp and was funded by the NICHD under a separate contract.
Role of the Sponsors: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) had a 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. The NICHD commissioned an expert panel of ethicists, regulatory experts, and attorneys to advise the investigators on the proper conduct of the Exception from Informed Consent; convened the Data Safety Monitoring Board; contracted with the Data Coordinating Center to provide data management and data analysis and to aid with interpretation of study results; reviewed the final manuscript prior to submission; and approved the final manuscript prior to submission.
Group Information: The Pediatric Emergency Care Applied Research Network (PECARN) includes the following investigators: Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC): The EMMES Corp: D. King, C. Kim, K. Martz, and J. Zhao. BPCA Data Monitoring Committee (DMC): P. Walson (chair), K. Weise, A. Das, D. Venzon, B. Wiedermann, G. Koren, C. Vocke, A. Thompson, N. Harris, M. Riddle, L. Brown, P. Swerdlow, and A. Zajicek. Participating centers and site investigators: Children’s Hospital, Boston: L. Nigrovic; Children’s Hospital of Buffalo: K. Lillis; Children’s Hospital of Michigan: P. Mahajan; Children’s Hospital of New York–Presbyterian: M. Sonnett; Children’s Hospital of Philadelphia: K. Shaw; Children’s Memorial Hospital: E. Powell; Children’s National Medical Center: K. Brown; Cincinnati Children’s Hospital Medical Center: R. Ruddy; DeVos Children’s Hospital: J. Hoyle; Hurley Medical Center: D. Borgialli; Jacobi Medical Center: Y. Atherly-John; Medical College of Wisconsin/Children’s Hospital of Wisconsin: M. Gorelick; University of California Davis Medical Center: E. Andrada; University of Michigan: R. Stanley; University of Rochester: G. Conners; University of Utah/Primary Children’s Medical Center: C. Pruitt; Washington University/St. Louis Children’s Hospital: D. Jaffe; University of Maryland: R. Lichenstein. PECARN Steering Committee: P. Dayan (chair); E. Alpern, L. Bajaj, K. Brown, D. Borgialli, J. Chamberlain, J. M. Dean, M. Gorelick, D. Jaffe, N. Kuppermann, M. Kwok, R. Lichenstein, K. Lillis, P. Mahajan, D. Monroe, L. Nigrovic, E. Powell, A. Rogers, R. Ruddy, R. Stanley, M. Tunik. MCHB/EMSC liaisons: D. Kavanaugh and H. Park. PECARN Data Coordinating Center (DCC): J. M. Dean, H. Gramse, R. Holubkov, A. Donaldson, C. Olson, S. Zuspan, and R. Enriquez. Feasibility and Budget Subcommittee (FABS): K. Brown, S. Goldfarb (co-chairs); E. Crain, E. Kim, S. Krug, D. Monroe, D. Nelson, M. Berlyant, and S. Zuspan. Grants and Publications Subcommittee (GAPS): M. Gorelick (chair); L. Alpern, J. Anders, D. Borgialli, L. Cimpello, A. Donaldson, G. Foltin, F. Moler, and K. Shreve. Protocol Review and Development Subcommittee (PRADS): L. Nigrovic (chair); J. Chamberlain, P. Dayan, JM. Dean, R. Holubkov, D. Jaffe, E. Powell, K. Shaw, R. Stanley, and M. Tunik. Quality Assurance Subcommittee (QAS): K. Lillis (chair); E. Alessandrini, S. Blumberg, R. Enriquez, R. Lichenstein, P. Mahajan, R. McDuffie, R. Ruddy, B. Thomas, and J. Wade. Safety and Regulatory Affairs Subcommittee (SRAS): W. Schalick, J. Hoyle, (co-chairs); S. Atabaki, K. Call, H. Gramse, M. Kwok, A. Rogers, D. Schnadower, and N. Kuppermann.