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Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06194396
Enrollment
100
Registered
2024-01-08
Start date
2023-05-01
Completion date
2024-07-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infection

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.

Interventions

OTHERchlorhexidine

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

OTHERalcohol

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

2 groups 50 neonates / group

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

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%.

Design outcomes

Primary

MeasureTime frameDescription
reduction in health care acquired neonatal infection8 monthsto determine whether the use of chlorhexidine 2% solution reduces the health care-acquired neonatal infection when compared to alcohol

Countries

Egypt

Contacts

Backup ContactMarwa Adel, Assoc Prof
01006383120
Primary ContactRania A El Farrash, Professor
rania.elfarrash@med.asu.edu.eg+20122228550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026