Actively Recruiting
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
Led by University of California, Berkeley · Updated on 2025-05-25
45450
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
Sponsors
U
University of California, Berkeley
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Public health care facility
- At least 25 live births per month
- Infrastructure compatible with inline chlorination device
- Pregnant adults or mature minors arriving at enrolled facilities to give birth and their neonates
You will not qualify if you...
- Existing facility-level chlorination
- Miscarriage before 28 weeks gestation
- Stillbirth (for neonatal analysis only)
- Unable to give informed consent or do not consent
- Reside more than 2 hours away from facility for enrollment into swab sampling cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of California, Berkeley
Berkeley, California, United States, 94720
Active, Not Recruiting
2
Kenya Medical Research Institute
Nairobi, Kenya
Actively Recruiting
Research Team
A
Amy J Pickering, PhD
CONTACT
Y
Yoshika Crider, PhD
CONTACT
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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