RECRUITING Not applicable ClinicalTrials.gov

Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates

Sponsor: University of California, Berkeley • ClinicalTrials.gov ID: NCT06824350

Registry updated: 2026-10-13

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

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

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 (Behavioral)
Infection prevention and control guidance and messaging

Eligibility 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 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

Conditions

Sepsis Neonatal Mortality Antibiotic Resistant Infection Enteric Infections Serious Bacterial Infection

Locations

University of California, Berkeley — Berkeley, California, United States
Kenya Medical Research Institute — Nairobi, Kenya

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment