Using Chlorhexidine baths to prevent infections in newborns in low-income countries
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
This study tests if giving newborns in hospitals a special bath with Chlorhexidine can help prevent infections and keep them safer in low-income countries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 1 Day to 6 Days |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Gaborone) |
| Trial ID | NCT06590675 on ClinicalTrials.gov |
What this trial studies
The CHARM study aims to evaluate the safety, efficacy, and feasibility of a locally prepared Chlorhexidine gluconate (CHG) bathing protocol for hospitalized neonates in low- and middle-income countries. This intervention targets the reduction of multidrug-resistant bacterial colonization and healthcare-associated infections among vulnerable newborns. By implementing a standardized, low-cost bathing protocol, the study seeks to improve infection control practices in neonatal units. The study will involve neonates aged 1-6 days who are expected to stay in the hospital for at least a week.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates aged 1-6 days admitted to a neonatal unit with an expected hospital stay of at least 7 days.
Not a fit: Patients who are underweight (less than 1kg), have a corrected gestational age of less than 28 weeks, or have current skin conditions or hypothermia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of multidrug-resistant infections in hospitalized neonates, improving survival rates.
How similar studies have performed: Previous studies have shown that CHG bathing can effectively reduce bacterial colonization in high-income settings, suggesting potential success in similar low-resource environments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates 1-6 days old admitted to the neo-natal unit expected to stay at least 7 days Exclusion Criteria: * Patients with a current weight of \<1kg * Patients with a current corrected gestational age of \<28 weeks (by Ballard score, or by dates if Ballard is not done) * Patients with a current diagnosis of hypothermia * Patients with a current diagnosis of skin rash or skin injury
Where this trial is running
Gaborone
- Princess Marina Hospital — Gaborone, Botswana (Recruiting)
Study contacts
- Principal investigator: Ebbing Lautenbach, MD,MPH,MSCE — University of Pennsylvania
- Study coordinator: Jonathan Strysko, MD, MSc
- Email: jstrysko@gmail.com
- Phone: 215-600-6455
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.