{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T13:58:58Z","timestamp":1790258338035,"version":"4.1.0"},"posted":{"date-parts":[[2026,9,21]]},"group-title":"Public and Global Health","reference-count":33,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Institutes of Health","award":["R01AI184756"],"award-info":[{"award-number":["R01AI184756"]}]},{"name":"Coefficient Giving"},{"name":"Global Innovation Fund"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,9,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The proportion of births occurring at healthcare facilities is rising globally, yet the birthing environment in healthcare facilities in low-income settings is often contaminated with bacterial pathogens, including antibiotic-resistant pathogens, that can lead to serious infections for newborns and their mothers. There is a need for effective strategies to reduce environmental contamination in healthcare facilities to reduce infection risks among facility-born neonates and their mothers.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>\n                    We designed the CLEAN (\n                    <jats:underline>C<\/jats:underline>\n                    h\n                    <jats:underline>L<\/jats:underline>\n                    orine to reduce\n                    <jats:underline>E<\/jats:underline>\n                    nteric and\n                    <jats:underline>A<\/jats:underline>\n                    ntibiotic resistant infections in\n                    <jats:underline>N<\/jats:underline>\n                    eonates) cluster randomized controlled trial in western Kenya to evaluate the impact of a multi-component chlorination intervention on environmental contamination and maternal and neonatal infection risks. Thirty-six medium-sized public health facilities will be randomized in a 1:1 allocation ratio to receive a passive chlorination technology for water supply treatment paired with a reliable supply of chlorine-based disinfectant or status quo. Up to 22,500 mothers-neonate dyads will be enrolled and followed from birth through 28 days to collect symptoms of infection and mortality, with a subset of mother-neonate dyads selected for rectal swab collection to measure rectal colonization with sepsis-associated bacterial species. Environmental samples will be collected to measure bacterial pathogens on staff hands, high-touch surfaces, and in water supply. The primary objectives of the study are to evaluate the impact of the intervention on the following outcomes: (1) rectal carriage of bacterial pathogens one week post-birth among facility-born neonates and their mothers, (2) cumulative incidence in the first 7 days post-birth of possible serious bacterial infection among facility-born neonates, and (3) cumulative incidence in the first 7 days post-birth of symptoms of possible maternal sepsis.\n                  <\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>This study will generate evidence on the effectiveness of a novel chlorination intervention to reduce healthcare associated infections, including antibiotic resistant infections, and improve maternal and neonatal survival.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>\n                    Clinical Trials\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06824350\">NCT06824350<\/jats:ext-link>\n                    . Registered 7 February 2025,\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT06824350\">https:\/\/clinicaltrials.gov\/study\/NCT06824350<\/jats:ext-link>\n                  <\/jats:p>\n                <\/jats:sec>","DOI":"10.64898\/2026.09.18.26363445","type":"posted-content","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T01:00:19Z","timestamp":1790038819000},"source":"Crossref","is-referenced-by-count":0,"title":["Multi-component chlorination intervention to reduce neonatal infections in healthcare facilities in western Kenya (CLEAN Trial): study protocol for a cluster randomized controlled trial"],"prefix":"10.64898","author":[{"given":"Yoshika S.","family":"Crider","sequence":"first","affiliation":[{"name":"Division of Environmental Health Sciences, University of Minnesota School of Public Health; Department of Civil & Environmental Engineering, University of California, Berkeley"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mwale","family":"Chiyenge","sequence":"additional","affiliation":[{"name":"Department of Civil & Environmental Engineering, University of California, Berkeley"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erick","family":"Odoyo","sequence":"additional","affiliation":[{"name":"Kenya Medical Research Institute\/Walter Reed Army Institute of Research-Africa, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joyce","family":"Kisiangani","sequence":"additional","affiliation":[{"name":"Department of Civil & Environmental Engineering, University of California, Berkeley; Division of Environmental Health Sciences, University of California, Berkeley, School of Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy","family":"Lowe","sequence":"additional","affiliation":[{"name":"Department of Civil & Environmental Engineering, University of California, Berkeley"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josline","family":"Wangia","sequence":"additional","affiliation":[{"name":"Kenya Medical Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blastus","family":"Bwire","sequence":"additional","affiliation":[{"name":"Remit Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mwanzia","family":"Kioko","sequence":"additional","affiliation":[{"name":"CARE Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly T.","family":"Alexander","sequence":"additional","affiliation":[{"name":"CARE USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Nekesa","sequence":"additional","affiliation":[{"name":"Remit Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lillian","family":"Musila","sequence":"additional","affiliation":[{"name":"Kenya Medical Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phelgona","family":"Otieno","sequence":"additional","affiliation":[{"name":"Kenya Medical Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6193-2221","authenticated-orcid":false,"given":"Amy J.","family":"Pickering","sequence":"additional","affiliation":[{"name":"Civil and Environmental Engineering, University of California, Berkeley; Biohub, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","reference":[{"key":"2026092406002739000_2026.09.18.26363445v1.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31575-6"},{"key":"2026092406002739000_2026.09.18.26363445v1.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2013.04.010"},{"key":"2026092406002739000_2026.09.18.26363445v1.3","unstructured":"A\/RES\/71\/313: Global indicator framework for the Sustainable Development Goals and targets of the 2030 Agenda for Sustainable Development [Internet]. 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