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

Recruiting now · Not applicable

Conditions studied: Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections, Serious Bacterial Infection

In brief

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.

Key facts

Study ID
NCT06824350
Run by
University of California, Berkeley
People needed
45450
Starts
2025-01-21
Expected to finish
2027-07-01
Last updated by the study team
2025-05-25

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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