Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates (NCT06824350) | Clinical Trial Compass
RecruitingNot Applicable
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
United States, Kenya45,450 participantsStarted 2025-01-21
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Possible serious bacterial infection in neonate
Timeframe: From birth to 7 days post birth
2
Possible maternal sepsis
Timeframe: From birth to 7 days post birth
3
Neonatal infection with at least one bacterial pathogen