Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

Not Applicable

Recruiting

• Conditions: Neonatal Infection
• Interventions: Other: alcohol; Other: chlorhexidine

• Registration Number: NCT06194396
• Lead Sponsor: Ain Shams University

Brief Summary

Chlorhexidine is a local antiseptic that has an important role in the prevention of catheter-associated bloodstream infections. Its application to a newborn's umbilical cord reduces all-cause neonatal mortality.

Detailed Description

Skin disinfection by an appropriate antiseptic agent is essential to prevent healthcare-associated infection. Common pathogens responsible for sepsis have been detected in skin microbiota of hospitalized neonates. Such skin inhabitants can cause sepsis and also lead to blood culture contamination resulting in unnecessary antibiotic use. Strict asepsis bundles have been shown to reduce catheter-related blood stream infection (CRBSI) and contamination rates. The choice of appropriate skin disinfectant is, however, based on low-quality evidence, even in adults.

Chlorhexidine gluconate (CHG) is a broad-spectrum antiseptic which is effective against a host of neonatal pathogens. CHG-based products are used frequently in the healthcare setting for peripheral and central venous catheter (CVC) site skin preparation, daily bathing of intensive care unit patients, full-body newborn skin cleansing, umbilical cord care, and Staphylococcus aureus decolonization.

In neonates, CHG used as antiseptic for CVC insertion site preparation and maintenance decreases CVC tip microbial colonization. Trials of full-body skin cleansing and umbilical cord care with CHG in the developing world, which included infants less than 34 weeks gestational age, have demonstrated reduced risk of neonatal mortality. Despite proven efficacy of CHG in neonates, current guidelines acknowledge that no recommendations with regards to CHG antisepsis can be made for infants less than 2 months of age due to incomplete safety data in this population.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-04
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 neonates using alcohol	alcohol	Alcohol will be used as skin disinfectant before insertion of the central venous catheter, PICC line, and umbilical venous catheter and during its routine care
50 neonates using chlorhexidine	chlorhexidine	Chlorhexidine will be used as skin disinfectant prior to insertion of the central venous catheter, PICC line, and umbilical venous catheter and during its routine care

Primary Outcome Measures

Name	Time	Method
reduction in health care acquired neonatal infection	8 months	to determine whether the use of chlorhexidine 2% solution reduces the health care-acquired neonatal infection when compared to alcohol

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt