Gonzalez, Daniel
,
Chamberlain, James M.
Guptill, Jeffrey T.
Cohen-Wolkowiez, Michael
Harper, Barrie
Zhao, Jian
Capparelli, Edmund V.
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (HHSN275201000003I, K23HD083465)
National Center for Advancing Translational Sciences (UL1TR001117)
National Institutes of Health (1R01-HD076676-01A1)
National Institute of Allergy and Infectious Diseases (HHSN272201500006I, HHSN272201300017I)
U.S. Food and Drug Administration (1U01FD004858-01)
Biomedical Advanced Research and Development Authority (HHSO100201300009C)
National Institute of Neurological Disorders and Stroke (K23NS085049)
Article History
First Online: 9 December 2016
Compliance with Ethical Standards
:
: This work was funded under National Institute of Child Health and Human Development (NICHD) contract HHSN275201000003I (principal investigator: Benjamin) for the Pediatric Trials Network. Research reported in this publication was also supported by the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) under award number UL1TR001117.
: Daniel Gonzalez receives research support from the NICHD (K23HD083465), the non-profit organization Thrasher Research Fund (ExternalRef removed), and from industry (Cempra, Inc. and Jacobus Pharmaceutical Company, Inc.) for drug development in adults and children. Michael Cohen-Wolkowiez receives research support from the NIH (1R01-HD076676-01A1), National Center for Advancing Translational Sciences of the NIH (UL1TR001117), National Institute of Allergy and Infectious Disease (NIAID; HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (1U01FD004858-01), Biomedical Advanced Research and Development Authority (BARDA; HHSO100201300009C), and the non-profit organization Thrasher Research Fund (ExternalRef removed) for drug development in adults and children (ExternalRef removed). Jeffrey T. Guptill receives research support through K23NS085049 from the National Institute of Neurological Disorders and Stroke (NINDS). James M. Chamberlain, Barrie Harper, Jian Zhao, and Edmund V. Capparelli have no conflicts of interest to disclose.The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
: Both pediatric studies were reviewed and approved by local Institutional Review Boards.
: For the StatusĀ 1 study, patients either pre-consented to participate in the study prior to the presentation of SE or consented to participate in the study after they received lorazepam if they presented to the Emergency Department with SE. For the StatusĀ 2 study, participating hospitals submitted a site-specific plan to their Institutional Review Board regarding the specific activities to address the requirements for the Exception from Informed Consent for Emergency Research (21 CFR 50.24). Thus, patients were treated prior to consent and then once their condition had stabilized the family was approached to discuss the study and obtain written consent for continued study participation.