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.
Public health care facility
25 live births or more per month
Infrastructure compatible with inline chlorination device
Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates
Existing facility-level chlorination
Miscarriage (<28 weeks gestation)
Stillbirth (for neonatal analysis only)
Unable to give informed consent/do not consent
Parallel
chlorination for water disinfection and surface disinfection
Device* 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.
infection prevention and control messaging
BehavioralInfection prevention and control guidance and messaging
Possible serious bacterial infection in neonate
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
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
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
Any symptom or sign of infection in neonate
One or more of the following symptoms: Difficulty feeding, Hyperthermia/fever, Hypothermia, Tachypnea, Severe chest indrawing, Convulsions, Movement only when stimulated/no movement, Bulging fontanel, Labored breathing, Skin infection, Umbilical redness, Oozing ears, Diarrhea, Three or more loose or watery stools in a 24 hour period, Vomiting, Cyanosis, Cough, Runny nose or congestion, Tachycardia (\>160 bpm at rest)
Any symptom or sign of infection in mother
One or more of the following symptoms: Hypothermia, Fever, Foul smelling vaginal discharge, Fits/convulsions, Tachycardia (\>100 bpm at rest), Low blood pressure, Diarrhea (self-defined), Difficulty breathing, Jaundice, Decreased urination or difficult or painful urination, Confusion or altered mental state, Mastitis, Chills, Body aches, Low appetite, Lower abdominal pain, Three or more loose or watery stools in a 24 hour period, Vomiting, Cough, Runny nose or congestion, Chest pain, Bloody stool, Skin infection
Clinical diagnosis of sepsis in neonate
Abstracted diagnosis from medical charts OR self-reported diagnosis confirmed by clinician
Clinical diagnosis of sepsis in mother
Abstracted diagnosis from medical charts OR self-reported diagnosis confirmed by clinician
Rectal colonization with individual bacterial pathogens (neonates)
Detection of individual bacterial pathogen by qPCR or by culture (see list in secondary outcomes)
Rectal colonization with individual bacterial pathogens (mothers)
Detection of individual bacterial pathogen (see pre-specified list in secondary outcomes) by culture or qPCR
Presence of individual ARGs in neonatal rectal swabs
Presence/absence of pre-specified clinically relevant ARGs by qPCR
Presence and concentration of bacterial pathogens on high touch surfaces
Measured by culture-based assays Includes: Acinetobacter spp., Pseudomonas spp., Salmonella spp., Shigella, Staphylococcus aureus, Group B streptococci
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University of California, Berkeley
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Kenya Medical Research Institute
Collaborator
Walter Reed Army Institute of Research (WRAIR)
Collaborator
