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

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.

NCT Number	NCT06824350
Lead Sponsor	University of California, Berkeley Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Kenya Medical Research Institute, Walter Reed Army Institute of Research (WRAIR)
Conditions	Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections, Serious Bacterial Infection
Enrollment	45,450 participants
Start Date	2025-01-21
Primary Completion	2027-07 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2025-05-25