Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups 50 neonates / group

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

alcohol

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

chlorhexidine

Intervention Type OTHER

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

Interventions

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chlorhexidine

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

Intervention Type OTHER

alcohol

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

Intervention Type OTHER

Eligibility Criteria

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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.