Comparing Chlorhexidine and Alcohol for Preventing Infections in Newborns
Effect of Chlorhexidine 2% Versus Alcohol on Healthcare Associated Infections in Neonates: Randomized Control Trial
This study tests whether using chlorhexidine instead of alcohol can better prevent infections in newborns who need catheters.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | N/A to 28 Days |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06194396 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of chlorhexidine compared to alcohol in preventing infections in neonates, particularly those requiring catheter insertion. It focuses on the role of chlorhexidine as a local antiseptic to reduce catheter-associated bloodstream infections and neonatal mortality. The study aims to provide better evidence for antiseptic use in newborns, especially in those with gestational ages of 28 weeks or more. By assessing the outcomes of these two antiseptics, the research seeks to establish a more effective protocol for infection prevention in vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates with a gestational age of 28 weeks or more who need catheter insertion.
Not a fit: Patients who are extremely preterm (less than 28 weeks gestational age) or have an allergy to chlorhexidine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce infection rates and improve survival outcomes for neonates requiring catheterization.
How similar studies have performed: Previous studies have shown the efficacy of chlorhexidine in reducing neonatal mortality in specific populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates with gestational age 28 weeks or more. * Neonates needing the insertion of a peripherally inserted central catheter (PICC line) or CVC or umbilical catheter. Exclusion Criteria: * Extremely preterm (GA less than 28 weeks). * Babies who have an allergy to chlorhexidine 2%.
Where this trial is running
Cairo
- Ain Shams University Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Rania El Farrash — Ain Shams University
- Study coordinator: Rania A El Farrash, Professor
- Email: rania.elfarrash@med.asu.edu.eg
- Phone: +20122228550
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.