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

Part of paid clinical trials in Berkeley, California.

Sponsor
University of California, Berkeley
Study ID
NCT06824350
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • chlorination for water disinfection and surface disinfection — DEVICE
    * 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.
  • infection prevention and control messaging — BEHAVIORAL
    Infection prevention and control guidance and messaging

Study Details

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 Dates

Start date
Jan 21, 2025
Status verified
May 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
45,450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Possible serious bacterial infection in neonate [ Time Frame: From birth to 7 days post birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, BerkeleyBerkeleyCalifornia94720-

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