Using chlorination to reduce infections in newborns
Multi-component Chlorination Intervention to Reduce Neonatal Infections in Rural Health Facilities
This study is testing if using chlorinated water in hospitals can help reduce infections in mothers and newborns in western Kenya.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45450 (estimated) |
| Sex | All |
| Sponsor | University of California, Berkeley Academic / other |
| Locations | 2 sites (Berkeley, California and 1 other locations) |
| Trial ID | NCT06824350 on ClinicalTrials.gov |
What this trial studies
The CLEAN trial evaluates the effectiveness of a chlorination intervention in healthcare facilities in western Kenya to improve maternal and neonatal health outcomes. This cluster randomized controlled trial involves 36 public health facilities, where some will receive a passive chlorination system for water treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and control facilities will also receive messaging on infection prevention and control. The study aims to assess the impact of this intervention on bacterial contamination in water supplies, healthcare worker hands, and high-touch surfaces, as well as the gut colonization of pathogenic and antibiotic-resistant bacteria in mothers and their newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant adults or mature minors arriving at participating healthcare facilities to give birth.
Not a fit: Patients who may not benefit from this study include those who experience miscarriage or stillbirth, as well as those who cannot provide informed consent.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of infections and improve survival rates among neonates in low-resource settings.
How similar studies have performed: Other studies have shown promising results with chlorination and infection control measures in healthcare settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Facility Inclusion Criteria: * Public health care facility * 25 live births or more per month * Infrastructure compatible with inline chlorination device Participant Inclusion Criteria: * Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates Facility Exclusion Criteria: * Existing facility-level chlorination Participant Exclusion Criteria: * 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
Where this trial is running
Berkeley, California and 1 other locations
- University of California, Berkeley — Berkeley, California, United States (Active_not_recruiting)
- Kenya Medical Research Institute — Nairobi, Kenya (Recruiting)
Study contacts
- Principal investigator: Amy J Pickering, PhD — University of California, Berkeley
- Study coordinator: Amy J Pickering, PhD
- Email: amyjanel@gmail.com
- Phone: 1-510-410-2666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.