Multi-component chlorination intervention to reduce neonatal infections in healthcare facilities in western Kenya (CLEAN Trial): study protocol for a cluster randomized controlled trial

The CLEAN study is a randomized controlled trial aimed at reducing infections in newborns and mothers in healthcare facilities in western Kenya. The study involves 36 healthcare facilities randomly assigned to either a multi-component chlorination intervention group (passive water treatment technology and chlorine-based disinfectant supply) or a control group with standard care. Up to 22,500 mother-neonate pairs will be enrolled and followed from birth through 28 days. Primary objectives include measuring bacterial carriage in the gut of newborns and mothers one week after birth, the incidence of serious bacterial infections in newborns within the first 7 days after birth, and the incidence of maternal sepsis symptoms within the first 7 days after birth. The study will also collect samples from healthcare workers' hands, surfaces, and water to detect bacterial pathogens. The results are expected to provide evidence on the effectiveness of chlorination in reducing healthcare-associated infections.