Updates are available Correction dated 2021-07-27

Article History

Received: 18 December 2020

Accepted: 15 February 2021

First Online: 26 February 2021

Change Date: 27 July 2021

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1186/s12887-021-02785-y

Ethics approval and consent to participate

: Baby-OSCAR received approval from the MHRA, the NHS Health Research Authority, and East Midlands – Nottingham 2 Research Ethics Committee: ExternalRef removed on 16 December 2014 (REC ref.: CitationRef removed/EM/0172). Trust Confirmation of Capacity and Capability was obtained at each site. The Chief Investigator or delegate will submit an Annual Progress Report, End of Study Notification, and Final Report to the Funder; NIHR HTA, MHRA, REC, HRA, host organisation and Sponsor.Where necessary, approvals are obtained from the above parties for all substantial amendments to the original approved documents and disseminated by NPEU CTU to relevant parties.Parents of eligible babies are provided with both verbal and written information in the form of a Parent Information Leaflet (Additional file InternalRef removed), by their clinical team. Parent(s) with legal parental responsibility of eligible babies are approached to discuss the trial further, answer any questions they may have, and to request consent. Parent(s) have as much time as they need to consider the information, and the opportunity to question the research team, or other independent parties to decide whether they wish to participate in the study. Informed consent for the study must obtained by a suitably qualified member of the study team. A parent must personally sign and date the latest approved version of the Informed Consent form (Additional file InternalRef removed) before any study specific procedures are performed. Parent(s) who do not speak English will only be approached if an adult interpreter is available.

: Not applicable.

: SG is member of steering committee of ESPR NPE (Neonatologist performed echocardiography). EJ was a member of the NIHR HTA General Board from 2016 to 2017 and the NIHR HTA Commissioning Board from 2013 to 2016. PH is currently a member of the NIHR HTA Commissioning Board. EJ, LL, NS and PH report receipt of funding from NIHR, outside the submitted work. NS receives fees for educational activities from Recordati Group.