RecruitingNot ApplicableNCT06824350

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

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


Sponsor

University of California, Berkeley

Enrollment

45,450 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria4

  • Public health care facility
  • 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

Exclusion Criteria5

  • Existing facility-level chlorination
  • Miscarriage (\<28 weeks gestation)
  • Stillbirth (for neonatal analysis only)
  • Unable to give informed consent/do not consent
  • Reside \>2 hours away from facility for enrollment into swab sampling cohort

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Interventions

DEVICEchlorination 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.

BEHAVIORALinfection prevention and control messaging

Infection prevention and control guidance and messaging


Locations(2)

University of California, Berkeley

Berkeley, California, United States

Kenya Medical Research Institute

Nairobi, Kenya

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NCT06824350


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