Andersson-Marforio, Sonja http://orcid.org/0000-0003-0122-763X
Lundkvist Josenby, Annika
Ekvall Hansson, Eva
Hansen, Christine
Funding for this research was provided by:
Academy of Caring Sciences (-)
Lions' Research grant (-)
Skåne University Hospital grant (-)
Skåne County Council's Research and Development Foundation (-)
Article History
Received: 20 December 2019
Accepted: 13 August 2020
First Online: 21 September 2020
Ethics approval and consent to participate
: Studies concerning infants need special ethical consideration as they belong to an especially vulnerable group, not being able to speak for themselves [CitationRef removed]. Because of this, the written information to the parents is detailed (see Additional file InternalRef removed), and the parents will be informed that participation in the study is voluntary and that they can withdraw at any time without this affecting the standard care of their child in any way. On the consent form, parents to participants will be informed that no unauthorised person can access personal data. The data will be un-personalised and coded with a trial ID number before analysis. No published material will contain identifiable participant information. This trial does not involve collecting biological specimens for storage.All changes of positions and movements will be done using close bodily contact with the infant, which is usually experienced as safe and positive for small children. The interventions are not expected to cause any pain or suffering to the infant. They will be regularly observed in different ways by the nursing staff and the parents. Thus also potential negative reactions will be documented in the study. The interventions that will be evaluated in the study are commonly in use in hospitals in Sweden. There is no anticipated harm and compensation for trial participation. Ordinary patient injury insurance applies as with all health care in the hospital. If the infants will need continued care post-trial, the standard care at the hospital will be available.The Regional Ethical Review Board in Lund, Sweden, approved the study in April 2017 (2017/190).
: Not applicable.
: The authors declare that they have no competing interests.