Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

Neonatal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194396
• Other study ID #: FMASU
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: Rania A El Farrash, Professor
• Phone: +20122228550
• Email: rania.elfarrash[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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%.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Neonatal Infection

Intervention

Other:
• chlorhexidine
chlorhexidine will be used as skin disinfectant before insertion of CVC, PICC line, and umbilical catheter
• alcohol
alcohol will be used as skin disinfectant before insertion of CVC ,PICC line and umbilical catheter

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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