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RECRUITING
NCT06824350
NA

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

Sponsor: University of California, Berkeley

View on ClinicalTrials.gov

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.

Official title: Multi-component Chlorination Intervention to Reduce Neonatal Infections in Rural Health Facilities

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

45450

Start Date

2025-01-21

Completion Date

2027-07

Last Updated

2025-05-25

Healthy Volunteers

Yes

Interventions

DEVICE

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.

BEHAVIORAL

infection prevention and control messaging

Infection prevention and control guidance and messaging

Locations (2)

University of California, Berkeley

Berkeley, California, United States

Kenya Medical Research Institute

Nairobi, Kenya