Chlorination Intervention to Reduce Neonatal and Maternal Infections in Rural Health Facilities in Kenya
Led by University of California, Berkeley · Updated on 2025-05-25
45450
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a multi-component chlorination intervention on maternal and neonatal health in public healthcare facilities in western Kenya. The trial focuses on reducing bacterial contamination and antibiotic-resistant infections in neonates born at these facilities. The study is a cluster randomized controlled trial involving 36 health facilities, with a goal to provide evidence on how chlorinated water supply and reliable chlorine disinfectant use impact bacterial contamination and infection rates.
Health facilities will be randomly assigned either to a control group or to an intervention group. Intervention facilities will receive passive inline chlorine dosers that automatically treat water used in maternity wards, along with a steady supply of chlorine disinfectant. Half of the intervention sites will produce chlorine on-site using electrochlorinators, while the other half will receive bulk chlorine deliveries. Both intervention and control facilities will receive infection prevention and control messaging. Facilities will also get equipment like mops and spray bottles for surface cleaning.
Participants include pregnant adults or mature minors giving birth at enrolled facilities and their newborns. Researchers will collect data over 24 months, assessing bacterial contamination in water, on hands, and on surfaces, as well as gut colonization by pathogenic and antibiotic-resistant bacteria in mothers and neonates. Health outcomes like possible serious bacterial infection and sepsis symptoms will be monitored during the first week after birth. The study will also track neonatal and maternal mortality up to 28 days postpartum to understand the interventions impact on infection and health.
CONDITIONS
Brief Title
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
Research Team
A
Amy J Pickering, PhD
Y
Yoshika Crider, PhD
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National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Chlorine-based Water and Surface Disinfection Plus IPC Messaging
Routine Infection Prevention and Control Messaging (No Facility Chlorination)
What it is
A multi-component facility-level infection control program combining inline chlorine dosers or bulk chlorine solution for automated water treatment, surface cleaning with chlorine, and dedicated equipment plus infection prevention/control messaging.
Routine infection prevention and control communication practices with no facility-level water or surface chlorination.
Role in the trial
Tested as the primary intervention to reduce neonatal and maternal infections and antimicrobial resistance via water and surface disinfection at the facility level.
Serves as the active comparator arm, reflecting routine practices in facilities lacking chlorination.
Primary use
To prevent possible or confirmed serious bacterial infections and reduce antibiotic-resistant infections in neonates and their mothers after facility-based delivery.
To represent current locally standard facility hygiene and infection prevention practices provided to mothers and newborns.
How it is given or performed
Inline chlorine dosers or periodic bulk chlorine delivery treat water automatically; additional chlorine solution is used for mopping and disinfecting surfaces, supported by dedicated cleaning tools, with staff receiving infection prevention/control messaging.
Standard cleaning and hygiene practices are followed; staff continue routine infection prevention and control messaging but do not receive new facility-level chlorination or disinfection interventions.
Evidence status
Effectiveness in reducing neonatal sepsis, maternal sepsis, and antimicrobial resistance is under investigation; results for this trial are not yet established. Supporting evidence from other studies shows reductions in diarrheal illness and improved water safety with inline chlorination elsewhere, but not specifically for neonatal infection outcomes in this population.
This is established facility practice in similar settings, but clinical effectiveness for prevention of neonatal serious bacterial infection or resistant infection is variable and influenced by local hygiene, infrastructure, and care quality.
Important limitations
Facility-level chlorination depends on proper installation, supply, user adherence, and may have logistical and maintenance challenges; many previous studies show water quality improvement but less clarity on sustained reduction of neonatal or maternal infection and antimicrobial resistance in varied healthcare settings.
Routine infection prevention messaging alone may not adequately prevent healthcare-associated neonatal infections where water quality and surface decontamination are suboptimal.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Public health care facility
At least 25 live births per month
Infrastructure suitable for inline chlorination device
Pregnant adults or mature minors arriving at enrolled facilities to give birth and their neonates
You will not qualify if you...
Facility already using chlorination
Miscarriage before 28 weeks gestation
Stillbirth (for neonatal analysis only)
Unable or unwilling to give informed consent
Living more than 2 hours away from facility for swab sampling cohort enrollment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Pregnant adults or mature minors arriving at enrolled facilities to give birth are assessed for eligibility.
Implementation
Duration - 24 months
Participants experience the installation and use of inline chlorine dosers for automated water disinfection and surface disinfection at the health facilities. Intervention includes infection prevention and control messaging.
Ongoing monitoring visits at health facilities throughout the study duration.
Post-birth Follow-up
Duration - 7 days post birth
Participants (mothers and neonates) are followed for symptoms of possible serious bacterial infection and colonization by bacterial pathogens in the week following birth.
Follow-up visits or assessments occur during the first week after birth.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial.