Weiss, Scott L. http://orcid.org/0000-0002-7040-3281
Balamuth, Fran
Long, Elliot
Thompson, Graham C.
Hayes, Katie L.
Katcoff, Hannah
Cook, Marlena
Tsemberis, Elena
Hickey, Christopher P.
Williams, Amanda
Williamson-Urquhart, Sarah
Borland, Meredith L.
Dalziel, Stuart R.
Gelbart, Ben
Freedman, Stephen B.
Babl, Franz E.
Huang, Jing
Kuppermann, Nathan
Long, E.
Williams, A.
Babl, F.
Borland, M.
O’Brien, S.
Craig, S.
Ramaga, E.
Kochar, A.
Nivea, G.
Jani, S.
Thosar, D.
Rao, A.
Phillips, N.
George, S.
Lithgow, A.
Mitchell, C.
Thompson, G.
Freedman, S.
Williamson-Urquhart, S.
Gilad, E.
Cooke, S.
Judge, P.
Murthy, S.
Kissoon, N.
Alqurashi, W.
Alnaji, F.
Sangha, G.
Mater, A.
Brashaw, M.
Curtis, S.
Joffe, A.
Shayan, Y.
Tucci, M.
Gripp, K.
Berthelot, S.
Weiss, M.
Davis, A.
Guifoyle, E.
Moretti, M.
Kam, A.
Parker, M.
Rochwerg, B.
Emsley, J.
Verma, N.
Sehgal, A.
Dalziel, S.
Bonisch, M.
Tan, E.
Neutze, J.
Balamuth, F.
Weiss, S.
Tsemberis, E.
Huang, J.
Cook, M.
Katcoff, H.
Hayes, K.
Hickey, C.
Eisenberg, M.
Lewander, D.
Morris, C.
Hurley, D.
Baumer-Mouradian, S.
Ambroggio, L.
Grice, K.
Festekjian, A.
Hickey, B.
Sada, R.
Dodson, J.
Badawy, M.
Lebel, C.
Elliott, M.
Koutralis, I.
Hom, K.
Eckerle, M.
Singleton, M.
Rogers, A.
Cervantes, V.
Duffy, S.
Bahamon, I.
Alpern, L.
Sirizi, A.
Ahmad, A. Haider
Banegas, A. Rubi
Lloyd, J.
DiCostanzo, K.
Kwok, M.
Ochs, J.
Lane, R.
Harbour, T.
Uspal, N.
Cappetto, K.
Clukies, L.
Robinsonm, D.
McManemy, J.
Gonzales, V.
Vance, C.
Kupperman, N.
Pimenta, K.
Mansour, K.
Lavrisha, L.
Ramirez, M.
Grad, J.
,
Funding for this research was provided by:
National Institute of Child Health and Human Development (R01HD101528)
Department of Public Health, Pennsylvania (SAP #4100085749)
Canadian Institutes of Health Research (173498)
Medical Research Futures Fund International Clinical Trial Collaboration (APP1190814)
Article History
Received: 25 May 2021
Accepted: 11 October 2021
First Online: 6 November 2021
Declarations
:
: A single Institutional Review Board at The Children's Hospital of Philadelphia is providing regulatory oversight for all US study sites (IRB #19-016484). In Canada, the University of Calgary will sponsor regulatory approval through Health Canada, while each site’s Research Ethics Board will oversee local human subjects’ protections, except sites in Ontario, for which centralized approval through Clinical Trials Ontario will be obtained (pending). A single ethics committee at The Royal Children’s Hospital Melbourne is providing regulatory oversight for Australia study sites (#68569). In New Zealand, a single ethics committee will provide regulatory oversight (pending).Prospective written informed consent will be sought from a legally authorized representative (LAR, e.g., at least one parent) prior to enrollment when sufficient time permits. Alternatively, enrollment may proceed in the US under the federal “Exception From Informed Consent” (EFIC, 21 CFR 50.24) for emergency research and in Canada and Australia/New Zealand with “deferred consent” in compliance with the Canadian Tri-Council Policy Statement-2 and National Statement on Ethical Conduct in Human Research, respectively. A waiver of assent will be requested due to the critical nature of illness in septic shock.
: Not applicable.
: The authors declare that they have no competing interests.