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

Every year, more and more mothers choose to give birth inside hospitals and clinics rather than at home. This shift is a sign of progress, offering access to skilled care when complications arise. However, in many low-income regions, the very walls and surfaces of these healthcare facilities can harbor invisible dangers. The air, the water, and the hands of the staff can carry microscopic organisms that cause serious illness. While these germs are a constant presence, they become particularly deadly for newborns, whose immune systems are just beginning to learn how to fight them. When these tiny patients are exposed to bacteria that have learned to resist common medicines, the risk of infection grows even higher. The central question for public health experts is not just how to treat these infections after they happen, but how to stop the environment itself from becoming a source of harm in the first place.

To answer this, researchers in western Kenya have launched a large-scale effort called the CLEAN trial, designed to test a straightforward yet powerful idea: using chlorine to clean the birthing environment. The study focuses on thirty-six medium-sized public health facilities, which the researchers have divided into two groups. One group will continue with their current methods, while the other will receive a new, multi-part system. This system introduces a passive technology that treats the water supply with chlorine, ensuring a steady flow of clean water, and pairs it with a reliable delivery of chlorine-based disinfectant for cleaning surfaces. The goal is to create a consistently cleaner space where mothers and babies can recover without being exposed to unnecessary pathogens.

The scope of the project is vast. Up to twenty-two thousand mother-and-baby pairs will be followed from the moment of birth through their first twenty-eight days of life. During this time, the team will track whether the babies and mothers show signs of serious bacterial infections or other symptoms of illness. To understand exactly what is happening inside their bodies, a smaller group of these families will also provide small samples from their rectums. These samples allow scientists to see if the bacteria that cause sepsis—a life-threatening reaction to infection—are taking up residence in the gut. At the same time, researchers will swab the hands of the staff, the high-touch surfaces in the rooms, and the water itself to measure the amount of bacteria present in the environment.

The study is looking for three specific results to determine if the chlorine intervention works. First, it will check if the babies and mothers in the treated facilities carry fewer of the dangerous bacteria in their bodies one week after birth. Second, it will count how many newborns develop signs of a serious bacterial infection within the first week of life. Third, it will monitor how many mothers show symptoms of sepsis during that same week. By comparing the results between the facilities that received the new cleaning system and those that did not, the researchers hope to see if a cleaner environment directly leads to fewer infections and better survival rates.

This work is still in its planning and execution phase, meaning the final answers are not yet known. The paper describes the design of the experiment and the methods the team will use to gather their data. If the results show a clear reduction in infections, it could prove that a simple, chemical-based approach to cleaning healthcare facilities is a powerful tool for saving lives. The ultimate aim is to generate solid evidence that could change how hospitals in similar settings manage their water and surfaces, turning the birthing room from a place of potential risk into a truly safe haven for new life.