Received: 17 December 2020
Accepted: 16 March 2021
First Online: 21 April 2021
: Ethics approval was granted by the King’s College London (UK) Research Ethics Subcommittee (LRS-14/15–1484) and in all countries before the start of the trial. Institutional-level consent on behalf of the cluster was obtained.This study was conducted in accordance with the current principles of the Declaration of Helsinki (October 2008. The conduct of this study was in full compliance with the relevant regulations and principles of Good Clinical Practice and equivalent guidance from our trial countries. Local ethical approval from each cluster has been granted: UnorderedList removedInstitutional-level consent on behalf of all subjects was obtained. In accord with recognised procedures for stepped-wedge trials primary outcome data was collected centrally rather than individually [CitationRef removed–CitationRef removed]. Informed written consent was obtained from health care professionals participating in focus groups, interviews and evaluation of the appropriateness of the referrals log. Institutional-level consent is appropriate considering the following: UnorderedList removed
: Not applicable.
: The CRADLE VSA has been developed by Microlife with academic input from King’s College London and funding from Bill and Melinda Gates. The device is provided at manufacturing cost for this trial and is available to purchase at low cost to all LMIC. King’s College London receive no funds from the sale of devices to LMIC. No authors declare any competing interests.