,
Maiwald, Christian A.
Niemarkt, Hendrik J.
Poets, Christian F.
Urschitz, Michael S.
König, Jochem
Hummler, Helmut
Bassler, Dirk
Engel, Corinna
Franz, Axel R. https://orcid.org/0000-0001-5066-0857
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (BMBF-Fz01KG1602)
Deutsche Forschungsgemeinschaft and the Open Access Publishing Fund of the University of Tübingen (-)
Article History
Received: 31 July 2019
Accepted: 20 September 2019
First Online: 21 October 2019
Ethics approval and consent to participate
: The FiO<sub>2</sub>-C trial is performed in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice (GCP). Patients can only be enrolled into the study after informed written consent was given by both parents/guardians (by the only parent/guardian in case of single-parent/guardian families). In case parents are less than 18 years of age, the relevant legal guardian(s) of the child has/have to sign the informed consent.At the time of publication, the FiO<sub>2</sub>-C trial is currently conducted in Germany and may expand to other countries, once ethical and (if appropriate) authority approval has been obtained.<i>Ethics: Ethics Committee at the University Hospital Tuebingen, reference no. 170/2018AMG1, approved;</i><i>Authority: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM),</i> reference no. 4042695 approved conduct.
: Not applicable.
: C.F. Poets received speaker honoraria from Masimo Inc. and Sentec. All other contributors declare that they do not have competing interest.