RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-21
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06824350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Public health care facility
  2. * 25 live births or more per month
  3. * Infrastructure compatible with inline chlorination device
  1. * Existing facility-level chlorination

Contacts and Locations

Study Contact

Amy J Pickering, PhD
CONTACT
1-510-410-2666
amyjanel@gmail.com
Yoshika Crider, PhD
CONTACT
1-785-550-5227
ycrider@berkeley.edu

Principal Investigator

Amy J Pickering, PhD
PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Phelgona Otieno, PhD
PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
Lillian Musila, PhD
PRINCIPAL_INVESTIGATOR
Walter Reed Army Institute of Research-Africa

Study Locations (Sites)

University of California, Berkeley
Berkeley, California, 94720
United States

Collaborators and Investigators

Sponsor: University of California, Berkeley

  • Amy J Pickering, PhD, PRINCIPAL_INVESTIGATOR, University of California, Berkeley
  • Phelgona Otieno, PhD, PRINCIPAL_INVESTIGATOR, Kenya Medical Research Institute
  • Lillian Musila, PhD, PRINCIPAL_INVESTIGATOR, Walter Reed Army Institute of Research-Africa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • infection prevention and control
  • antibiotic resistance
  • bacterial enteric infection
  • neonatal mortality
  • sepsis
  • water disinfection
  • chlorine
  • sodium hypochlorite
  • hospital acquired infections

Additional Relevant MeSH Terms

  • Sepsis
  • Neonatal Mortality
  • Antibiotic Resistant Infection
  • Enteric Infections
  • Serious Bacterial Infection