CLEAN Trial: Chlorination to Reduce Infections in Newborns
This study, called the CLEAN Trial, is looking at how using chlorine for water and surface disinfection in healthcare facilities in Kenya can reduce serious infections in newborns (neonates) and their mothers. The intervention involves installing devices for automatic water chlorination and providing chlorine solution for cleaning. Both facilities receiving chlorine and those not will also get guidance on preventing infections. Researchers will measure if this approach reduces serious bacterial infections and maternal sepsis (a severe infection after childbirth) in the first 7 days after birth. The study aims to enroll 45,450 participants. You might be able to participate if you are a pregnant adult or mature minor giving birth at one of the enrolled public healthcare facilities that has at least 25 live births per month and compatible infrastructure for the chlorination device.
- Study design
- This is an interventional study, meaning participants receive a specific treatment. It is a cluster randomized controlled trial, where 36 healthcare facilities will be randomly assigned to either receive the chlorination intervention or not.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure outcomes like possible serious bacterial infection and maternal sepsis from birth to 7 days post birth, and neonatal infection with at least one bacterial pathogen at 7 days after birth.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- 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
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Possible serious bacterial infection in neonateFrom 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 sepsisFrom 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 pathogen7 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