Ngwalangwa, Fatsani
Nyaika, Margaret
Baker, Tim
Dube, Queen
Langton, Josephine
Hildenwall, Helena
Funding for this research was provided by:
Vetenskapsrådet
Article History
Received: 21 July 2025
Accepted: 17 February 2026
First Online: 3 March 2026
Declarations
:
: was obtained from the University of Malawi’s College of Medicine Research and Ethics Committee (COMREC P.01/16/1852) as well as the Central Ethical Research Board in Sweden (EPN 2017/33 − 31/4). The Ethical approval for the study was obtained at the same time as the main study. A written informed consent was obtained from caretakers of children who participated in the study before enrolment into the study. Assent was also obtained from all children older than seven years old. In case the child’s clinical condition was so urgent that any treatment delay was harmful, a full consent for participation was deferred until after stabilizing treatment had been initiated. The informed consent and assent were obtained by our study nurses and clinical officers. An independent Data and Safety Monitoring Board (DSMB) was instituted to oversee the safety of the study participants. This consisted of two epidemiologists, a paediatrician and a biostatistician who were all familiar with the study setting. Trial monitoring was also conducted on predetermined times by an independent clinical trial monitoring team. The research was conducted in compliance with the Helsinki Declaration.
: Not applicable.
: The authors declare no competing interests.