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Life sciences · Interventional Study
ClinicalTrials.gov · October 13, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06824350). This is a study registration, not published results. Lead sponsor: University of California, Berkeley. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 45450 participants (ESTIMATED). Conditions: Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections, Serious Bacterial Infection. Interventions: DEVICE: chlorination for water disinfection and surface disinfection; BEHAVIORAL: infection prevention and control messaging. Primary outcome measures: Possible serious bacterial infection in neonate , From birth to 7 days post birth; Possible maternal sepsis , From birth to 7 days post birth; Neonatal infection with at least one bacterial pathogen , 7 days after birth; Neonatal rectal colonization with at least one bacterial pathogen by culture-based method measured 7 days after birth , Approx 7 days after birth; Rectal colonization with one or more antibiotic resistant bacteria (neonates) , Approx 7 days after birth. Brief summary: 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 resistant bacteria one week post-birth, and (3) symptoms of possible serious bacterial infection one week following birth.