{
  "abstract": "BackgroundThe 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.\n\nMethodsWe designed the CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) 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\nDiscussionThis 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.\n\nTrial registrationClinical Trials NCT06824350. Registered 7 February 2025, https://clinicaltrials.gov/study/NCT06824350",
  "abstract_shown": true,
  "affiliations": [
    "University of California, Berkeley"
  ],
  "article_type": "PUBLISHAHEADOFPRINT",
  "arxiv": null,
  "author_total": 13,
  "authors": [
    {
      "name": "Y. Crider"
    },
    {
      "name": "M. Chiyenge"
    },
    {
      "name": "E. Odoyo"
    },
    {
      "name": "J. Kisiangani"
    },
    {
      "name": "J. Lowe"
    },
    {
      "name": "J. Wangia"
    },
    {
      "name": "B. Bwire"
    },
    {
      "name": "M. Kioko"
    },
    {
      "name": "K. Alexander"
    },
    {
      "name": "C. Nekesa"
    },
    {
      "name": "L. Musila"
    },
    {
      "name": "P. Otieno"
    },
    {
      "affs": [
        0
      ],
      "name": "A. Pickering"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9mdv3w7zx1swy.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.09.18.26363445",
  "fulltext_url": "https://www.medrxiv.org/content/10.64898/2026.09.18.26363445v1.full",
  "id": "9mdv3w7zx1swy",
  "issns": [],
  "landing_url": "https://www.medrxiv.org/content/10.64898/2026.09.18.26363445v1",
  "language": null,
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "medrxiv",
      "public and global health"
    ],
    [
      "openalex",
      "2725|Infection Control in Healthcare"
    ]
  ],
  "openalex": "W7213878369",
  "pdf_url": "https://www.medrxiv.org/content/10.64898/2026.09.18.26363445v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-09-18",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/9mdv3w7zx1swy.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:04Z",
      "native_id": "10.64898/2026.09.18.26363445",
      "source": "medrxiv",
      "url": "https://www.medrxiv.org/content/10.64898/2026.09.18.26363445v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "medrxiv:public and global health",
      "subfield": "epidemiology-public-health"
    }
  ],
  "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",
  "title_text": "Multi-component chlorination intervention to reduce neonatal infections in healthcare facilities in western Kenya (CLEAN Trial): study protocol for a cluster randomized controlled trial",
  "type": "preprint",
  "updated_at": "2026-10-30T12:19:04Z",
  "url": "https://research.draconitic.com/paper/9mdv3w7zx1swy",
  "venue": "medRxiv",
  "versions": []
}