Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
Launched by UNIVERSITY OF CALIFORNIA, BERKELEY · Feb 7, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The CLEAN Trial is a research study taking place in western Kenya that aims to improve the health of mothers and newborns by using a special water treatment method. The trial will test whether adding chlorine to the water in healthcare facilities can reduce infections caused by bacteria, especially those that are resistant to antibiotics. This includes checking how clean the water is and ensuring that staff and surfaces in maternity wards are free of harmful germs. Researchers will look at whether this method helps prevent serious infections in newborns and their mothers during the first week after birth.
To participate in this study, you need to be a pregnant adult or mature minor planning to give birth at a specific public health facility that has at least 25 live births a month and can use the chlorine treatment. Unfortunately, if you have had a miscarriage or stillbirth, you will not be eligible for the study. Participants can expect to receive information about infection prevention, and researchers will take samples to check for germs in the mothers and their babies after delivery. This study is important because it could lead to new ways to protect newborns from infections, ultimately saving lives.
Gender
ALL
Eligibility criteria
- Facility Inclusion Criteria:
- • Public health care facility
- • 25 live births or more per month
- • Infrastructure compatible with inline chlorination device
- Participant Inclusion Criteria:
- • Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates
- Facility Exclusion Criteria:
- • Existing facility-level chlorination
- Participant Exclusion Criteria:
- • Miscarriage (\<28 weeks gestation)
- • Stillbirth (for neonatal analysis only)
- • Unable to give informed consent/do not consent
- • Reside \>2 hours away from facility for enrollment into swab sampling cohort
About University Of California, Berkeley
The University of California, Berkeley, a leading research institution renowned for its commitment to scientific innovation and academic excellence, serves as a prominent sponsor of clinical trials aimed at advancing medical knowledge and improving patient outcomes. With a robust infrastructure for interdisciplinary collaboration, UC Berkeley leverages its distinguished faculty, cutting-edge laboratories, and extensive resources to conduct research that addresses critical health challenges. The university is dedicated to fostering a culture of ethical research practices and ensuring the highest standards of safety and efficacy in its clinical investigations, ultimately contributing to the translation of scientific discoveries into tangible health solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nairobi, , Kenya
Berkeley, California, United States
Patients applied
Trial Officials
Amy J Pickering, PhD
Principal Investigator
University of California, Berkeley
Phelgona Otieno, PhD
Principal Investigator
Kenya Medical Research Institute
Lillian Musila, PhD
Principal Investigator
Walter Reed Army Institute of Research-Africa
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported