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Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates

RecruitingNAAges any - anyAllUniversity of California, Berkeley
NCT06824350 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and treatment facilities will receive infection prevention and control messaging. The goal of the study is to evaluate the impact of the intervention on bacterial contamination of water supply, on staff hands, and on high-touch surfaces in maternity wards, and the following outcomes among facility-born neonates and their mothers: (1) gut carriage of bacterial pathogens associated with sepsis one week post-birth, (2) gut carriage of antibiotic resista

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📋 Eligibility rules (as published)
Facility Inclusion Criteria: * Public health care facility * 25 live births or more per month * Infrastructure compatible with inline chlorination device Participant Inclusion Criteria: * Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates Facility Exclusion Criteria: * Existing facility-level chlorination Participant Exclusion Criteria: * Miscarriage (\<28 weeks gestation) * Stillbirth (for neonatal analysis only) * Unable to give informed consent/do not consent * Reside \>2 hours away from facility for enrollment into swab sampling cohort
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What it tests

  • chlorination for water disinfection and surface disinfection
  • infection prevention and control messaging
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Where

2 sites
University of California, Berkeley
Berkeley, United States
Kenya Medical Research Institute
Nairobi, Kenya
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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