Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

Effect of Chlorhexidine 2% Versus Alcohol on Healthcare Associated Infections in Neonates: Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Infection
• Intervention / Treatment: Other: alcohol; Other: chlorhexidine

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rania A El Farrash, Professor; Phone Number: +20122228550; Email: rania.elfarrash@med.asu.edu.eg
• Study Contact Backup: Name: Marwa Adel, Assoc Prof; Phone Number: 01006383120

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Ain Shams University Hospital
    • Contact: Marwa Adel, Assoc Prof; Phone Number: 01006383120
    • Contact: Rania El Farrash, Professor; Phone Number: +20122228550; Email: rania.elfarrash@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 50 neonates using 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	Other: alcohol; alcohol will be used as skin disinfectant before insertion of CVC ,PICC line and umbilical catheter
Experimental: 50 neonates using 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	Other: chlorhexidine; chlorhexidine will be used as skin disinfectant before insertion of CVC, PICC line, and umbilical catheter

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Rania El Farrash, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: FMASU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No