About this trial
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.
Eligibility criteria
Qualifiers
Public health care facility
25 live births or more per month
Infrastructure compatible with inline chlorination device
Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates
Disqualifiers
Existing facility-level chlorination
Miscarriage (<28 weeks gestation)
Stillbirth (for neonatal analysis only)
Unable to give informed consent/do not consent
Trial design
Treatments tested in this trial
- chlorination for water disinfection and surface disinfection
- infection prevention and control messaging
Treatment groups
Sponsors and collaborators
University of California, Berkeley
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Kenya Medical Research Institute
Collaborator
Walter Reed Army Institute of Research (WRAIR)
Collaborator