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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

Locations
United States
California
University of California, Berkeley
ACTIVE_NOT_RECRUITING
Berkeley
Other Locations
Kenya
Kenya Medical Research Institute
RECRUITING
Nairobi
Contact Information
Primary
Amy J Pickering, PhD
amyjanel@gmail.com
1-510-410-2666
Backup
Yoshika Crider, PhD
ycrider@berkeley.edu
1-785-550-5227
Time Frame
Start Date: 2025-01-21
Estimated Completion Date: 2027-07
Participants
Target number of participants: 45450
Treatments
Active_comparator: Control
Control group. At the conclusion of the trial, facilities will receive a chlorine doser.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Walter Reed Army Institute of Research (WRAIR), Kenya Medical Research Institute
Leads: University of California, Berkeley

This content was sourced from clinicaltrials.gov