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

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.

Conditions

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

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Kenya Medical Research Institute

  collaborator OTHER

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• University of California, Berkeley

  lead OTHER

Principal Investigators

• Amy J Pickering, PhD · University of California, Berkeley

• Phelgona Otieno, PhD · Kenya Medical Research Institute

• Lillian Musila, PhD · Walter Reed Army Institute of Research-Africa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-21

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• United States
• Kenya

Study Locations