Multi-component Chlorination Intervention to Reduce Neonatal Infections in Rural Health Facilities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 45,450
- Locations
- 2
- Primary Endpoint
- Possible serious bacterial infection in neonate
Study Overview
Brief 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.
Detailed Description
The proportion of births occurring at healthcare facilities is rising globally, yet healthcare facilities in low-income settings have been found to be highly contaminated with bacterial pathogens, including antibiotic resistant pathogens. There is a need for effective strategies to reduce contamination in healthcare facilities in order to reduce infection risks among facility-born neonates. In this trial, medium-sized public health facilities will be randomized to control or to receive an intervention consisting of passive chlorination for water supply treatment and a reliable supply of chlorine disinfectant. Reliable supply is randomized as either (a) an electrochlorinator for on-site production or (b) bulk chlorine delivery.
This cluster randomized controlled trial will enroll 36 health facilities to generate rigorous evidence on the maternal and neonatal health benefits of chlorinated water supply paired with reliable supplies of chlorine disinfectant. This study has the following aims: 1) determine the impact of the intervention on pathogenic and antibiotic resistant bacterial contamination in water supplies, on high-touch surfaces, and on healthcare worker hands, 2) quantify intervention effects on gut colonization of mothers and neonates by a panel of pathogenic and antibiotic resistant bacteria species linked to serious infection, using molecular and culture-based methods, and 3) follow up with mother-neonate dyads to measure intervention effects on symptoms of possible serious bacterial infection in the week following birth. Data collection will be for a duration of 24 months.
Infection prevention through effective water, sanitation, and hygiene (WASH) has been cited by national action plans as a key tool in the fight against antimicrobial resistance and, while global data show dire WASH conditions in low- and middle-income (LMIC) health facilities, there exists very little guidance for implementing effective interventions. The overarching goal is to generate actionable evidence to inform investments in chlorination at health facilities to improve maternal and neonatal health and reduce the threat of antibiotic resistant infections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Lab technicians will be masked to intervention status of samples received. A subset of investigators will be masked to outcomes by intervention status until data collection is complete.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
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
Arms & Interventions
Control
Control group. At the conclusion of the trial, facilities will receive a chlorine doser.
Intervention: infection prevention and control messaging (Behavioral)
Multi-component chlorine intervention
Health care facilities will receive one or more inline chlorine dosers that will automatically chlorinate all water accessed by the maternity wards. Intervention facilities will also be randomized to either receive an electrochlorinator for on-site production of liquid chlorine solution or to receive bulk chlorine deliveries. Chlorine will be use to refill the chlorine dosers and for surface disinfection. Facilities will also receive hardware to facilitate surface disinfection.
Intervention: chlorination for water disinfection and surface disinfection (Device)
Multi-component chlorine intervention
Health care facilities will receive one or more inline chlorine dosers that will automatically chlorinate all water accessed by the maternity wards. Intervention facilities will also be randomized to either receive an electrochlorinator for on-site production of liquid chlorine solution or to receive bulk chlorine deliveries. Chlorine will be use to refill the chlorine dosers and for surface disinfection. Facilities will also receive hardware to facilitate surface disinfection.
Intervention: infection prevention and control messaging (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Clinical diagnosis of sepsis in mother(From birth to 7 days post birth)
- Any symptom or sign of infection in neonate(From birth until 7 days post birth)
- Any symptom or sign of infection in mother(From birth to 7 days post birth)
- Clinical diagnosis of sepsis in neonate(From birth to 7 days post birth)
- Neonatal mortality(From birth to 28 days after birth)
- Neonatal rectal colonization with at least one bacterial pathogen by culture(7 days after birth)
- Number of bacterial pathogens in rectal swabs (mothers)(7 days postpartum)
- Maternal mortality(From birth to 28 days after birth)
- Maternal rectal colonization with at least one bacterial pathogen by culture-based method(7 days postpartum)
- Number of clinically relevant antibiotic resistance genes (ARGs) detected in neonatal rectal swabs(7 days post birth)
- Rectal colonization with one or more antibiotic resistant bacteria (neonates)(7 days post birth)
- Rectal colonization with one or more antibiotic resistant bacteria (mothers)(7 days postpartum)
- Number of bacterial pathogens in rectal swabs (neonates)(7 days post birth)