Coleman, Jesse https://orcid.org/0000-0002-3601-7854
Ginsburg, Amy Sarah
Macharia, William M.
Ochieng, Roseline
Chomba, Dorothy
Zhou, Guohai
Dunsmuir, Dustin
Karlen, Walter
Ansermino, J. Mark
Funding for this research was provided by:
Bill and Melinda Gates Foundation (OPP1196617)
Article History
Received: 18 August 2021
Accepted: 2 March 2022
First Online: 25 March 2022
Declarations
:
: All authors declare no competing interests.
: The study was conducted per the International Conference on Harmonisation Good Clinical Practice and the Declaration of Helsinki 2008. The protocol and other relevant study documents were approved by Western Institutional Review Board (20191102; Puyallup, Washington, USA), Aga Khan University Nairobi Research Ethics Committee (2019/REC-02 v2; Nairobi, Kenya), Kenyan Pharmacy and Poisons Board (19/05/02/2019(078)), and Kenyan National Commission for Science, Technology and Innovation (NACOSTI/P/19/68024/30253).
: Written informed consent was obtained in English or Swahili by trained study staff from each neonate’s caregiver according to a checklist that included ascertainment of caregiver comprehension.
: N/A