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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, Berkeley

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Existing facility-level chlorination

Miscarriage (<28 weeks gestation)

Stillbirth (for neonatal analysis only)

Unable to give informed consent/do not consent

Trial design

Treatments tested in this trial

  • chlorination for water disinfection and surface disinfection
  • infection prevention and control messaging

Treatment groups

45,450 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Berkeley

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Kenya Medical Research Institute

Collaborator

Walter Reed Army Institute of Research (WRAIR)

Collaborator