Comparing chlorhexidine and alcohol hand rubs to reduce infections in the NICU

a Comparison Between Effect of Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection

This project will test whether chlorhexidine or alcohol hand rubs work better to reduce healthcare-associated infections in premature newborns in the neonatal intensive care unit.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 6 Hours to 1 Day
• Sex: All
• Sponsor: Alexandria University (Academic / other)
• Locations: 1 site (Alexandria)
• Trial ID: NCT07421323 on ClinicalTrials.gov

What this trial studies

Neonates under 37 weeks gestation admitted to the Alexandria University Children's Hospital NICU will be assigned to care where staff use either alcohol-based hand rub or chlorhexidine gluconate for hand hygiene. The trial compares rates of healthcare-associated infections between the two hand-rub approaches. Infants with major congenital abnormalities, immunodeficiency, inborn errors of metabolism, early-onset sepsis, or who are older than 72 hours at enrollment are excluded, and parental consent is required. Primary outcomes focus on incidence of neonatal sepsis and other HCAIs during the NICU stay.

Who should consider this trial

Good fit: Premature neonates (<37 weeks gestation) admitted to the Alexandria University Children's Hospital NICU within 72 hours of birth who do not have major congenital anomalies, immunodeficiency, inborn metabolic errors, or early-onset sepsis and whose parents consent.

Not a fit: Infants with early-onset sepsis, major congenital abnormalities, known immunodeficiency or metabolic disorders, those older than 72 hours at presentation, or those without parental consent are not eligible and would not receive benefit from enrollment.

Why it matters

Potential benefit: If successful, this could lower healthcare-associated infection rates and related complications among preterm infants in the NICU.

How similar studies have performed: Alcohol-based hand rubs are widely shown to reduce healthcare-associated infections and chlorhexidine is an effective antiseptic, but direct head-to-head evidence in preterm NICU populations is limited.

Eligibility criteria

Inclusion Criteria:

Neonates \<37 weeks gestational age admitted to NICU of Alexandria University Children's Hospitals

Exclusion Criteria:

* Patients with any of the following will be excluded:

  1. Obvious major congenital abnormalities, immunodeficiency and inborn error of metabolism.
  2. Early onset sepsis (before the third day).
  3. Infants more than 72 hours of age at the time of randomization.
  4. Parental consent lacking/refusal.

Where this trial is running

Alexandria

• Marwa Mohamed Farag — Alexandria, Egypt (Recruiting)

Conditions Neonatal Sepsis