NCT06824350 · University of California, Berkeley
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
(CLEAN)
What this study is about
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomly assigned controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health.
View original scientific description
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.
Interventions
DEVICE
chlorination for water disinfection and surface disinfection
* Installation of inline chlorine doser(s) for automated water disinfection. * Provision of chlorine solution for water and surface disinfection (half of treatment facilities randomized to receive electrochlorinator, half receive bulk chlorine solution deliveries). * Provision of mop(s), bucket(s), and spray bottles for surface cleaning.
BEHAVIORAL
infection prevention and control messaging
Infection prevention and control guidance and messaging
Primary outcome measures
Possible serious bacterial infection in neonate
Time frame: From birth to 7 days post birth
Incidence of one or more of the following severe infection symptoms of neonates based on WHO criteria for possible serious bacterial infection: 1. Not able to feed at all or not feeding well 2. Convulsions 3. Severe chest indrawing 4. Fever - High body temperature (38°C\* or above) 5. Low body temperature (less than 35.5°C\*) 6. Movement only when stimulated or no movement at all 7. Fast breathing (60 breaths per minute or more)
Possible maternal sepsis
Time frame: From birth to 7 days post birth
Any of the following listed with fever or hypothermia: 1. fast heartbeat 2. low blood pressure 3. respiratory distress 4. jaundice 5. decreased urination/dysuria 6. altered mental status
Neonatal infection with at least one bacterial pathogen
Time frame: 7 days after birth
Detection of any pre-specified bacterial pathogen detected by qPCR in infant rectal swabs (among swab subset of participants) Includes: ETEC, STEC, EPEC, EAEC, EIEC, EHEC O157:H7, Escherichia coli/Shigella, Shigella spp, Shigella flexneri, Salmonella spp., Salmonella enteritidis, Salmonella typhi, Campylobacter jejuni/coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Streptococcus agalactiae (Group B strep), Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter baumannii, Clostridium difficile, Vibrio cholerae
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Berkeley, California
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Kenya Medical Research Institute, Walter Reed Army Institute of Research (WRAIR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 25, 2025 · Source of record for eligibility and locations