Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
NCT ID: NCT06824350
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45450 participants
INTERVENTIONAL
2025-01-21
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
Control group. At the conclusion of the trial, facilities will receive a chlorine doser.
infection prevention and control messaging
Infection prevention and control guidance and messaging
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.
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.
infection prevention and control messaging
Infection prevention and control guidance and messaging
Interventions
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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.
infection prevention and control messaging
Infection prevention and control guidance and messaging
Eligibility Criteria
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Inclusion Criteria
* 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
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
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Kenya Medical Research Institute
OTHER
Walter Reed Army Institute of Research (WRAIR)
FED
University of California, Berkeley
OTHER
Responsible Party
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Principal Investigators
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Amy J Pickering, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Phelgona Otieno, PhD
Role: PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
Lillian Musila, PhD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Institute of Research-Africa
Locations
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University of California, Berkeley
Berkeley, California, United States
Kenya Medical Research Institute
Nairobi, , Kenya
Countries
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Central Contacts
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Facility Contacts
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References
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Lindmark M, Cherukumilli K, Crider YS, Marcenac P, Lozier M, Voth-Gaeddert L, Lantagne DS, Mihelcic JR, Zhang QM, Just C, Pickering AJ. Passive In-Line Chlorination for Drinking Water Disinfection: A Critical Review. Environ Sci Technol. 2022 Jul 5;56(13):9164-9181. doi: 10.1021/acs.est.1c08580. Epub 2022 Jun 14.
Pickering AJ, Crider Y, Sultana S, Swarthout J, Goddard FG, Anjerul Islam S, Sen S, Ayyagari R, Luby SP. Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial. Lancet Glob Health. 2019 Sep;7(9):e1247-e1256. doi: 10.1016/S2214-109X(19)30315-8.
Other Identifiers
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2024-01-17100
Identifier Type: -
Identifier Source: org_study_id
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