Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID06824350

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

Led by University of California, Berkeley · Updated on 2025-05-25

45450

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, Berkeley

Lead Sponsor

N

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of a multi-component chlorination intervention on maternal and neonatal health in public healthcare facilities in western Kenya. The trial focuses on reducing bacterial contamination and antibiotic-resistant infections in neonates born at these facilities. The study is a cluster randomized controlled trial involving 36 health facilities, with a goal to provide evidence on how chlorinated water supply and reliable chlorine disinfectant use impact bacterial contamination and infection rates. Health facilities will be randomly assigned either to a control group or to an intervention group. Intervention facilities will receive passive inline chlorine dosers that automatically treat water used in maternity wards, along with a steady supply of chlorine disinfectant. Half of the intervention sites will produce chlorine on-site using electrochlorinators, while the other half will receive bulk chlorine deliveries. Both intervention and control facilities will receive infection prevention and control messaging. Facilities will also get equipment like mops and spray bottles for surface cleaning. Participants include pregnant adults or mature minors giving birth at enrolled facilities and their newborns. Researchers will collect data over 24 months, assessing bacterial contamination in water, on hands, and on surfaces, as well as gut colonization by pathogenic and antibiotic-resistant bacteria in mothers and neonates. Health outcomes like possible serious bacterial infection and sepsis symptoms will be monitored during the first week after birth. The study will also track neonatal and maternal mortality up to 28 days postpartum to understand the intervention's impact on infection and health.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Public health care facility
  • At least 25 live births per month
  • Infrastructure suitable for inline chlorination device
  • Pregnant adults or mature minors arriving at enrolled facilities to give birth and their neonates
Not Eligible

You will not qualify if you...

  • Facility already using chlorination
  • Miscarriage before 28 weeks gestation
  • Stillbirth (for neonatal analysis only)
  • Unable or unwilling to give informed consent
  • Living more than 2 hours away from facility for swab sampling cohort enrollment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Pregnant adults or mature minors arriving at enrolled facilities to give birth are assessed for eligibility.

Implementation

Duration - 24 months

Participants experience the installation and use of inline chlorine dosers for automated water disinfection and surface disinfection at the health facilities. Intervention includes infection prevention and control messaging.

Ongoing monitoring visits at health facilities throughout the study duration.

Post-birth Follow-up

Duration - 7 days post birth

Participants (mothers and neonates) are followed for symptoms of possible serious bacterial infection and colonization by bacterial pathogens in the week following birth.

Follow-up visits or assessments occur during the first week after birth.

Trial Site Locations

Total: 2 locations

1

University of California, Berkeley

Berkeley, California, United States, 94720

Active, Not Recruiting

2

Kenya Medical Research Institute

Nairobi, Kenya

Actively Recruiting

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Research Team

A

Amy J Pickering, PhD

Y

Yoshika Crider, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial.

Amy J Pickering, Yoshika Crider, Sonia Sultana...

https://pubmed.ncbi.nlm.nih.gov/31402005