Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

NCT06194396 | Recruiting DMC

• 1 other identifier: FMASU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

50 neonates using alcohol

ACTIVE COMPARATOR

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

50 neonates using chlorhexidine

EXPERIMENTAL

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

Interventions

chlorhexidine OTHER

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

50 neonates using chlorhexidine

alcohol OTHER

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

50 neonates using alcohol

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Extremely preterm (GA less than 28 weeks).
• Babies who have an allergy to chlorhexidine 2%.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Interventions

Chlorhexidine; Ethanol

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Alcohols

Study Officials

• Rania El Farrash

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania A El Farrash, Professor

CONTACT

+20122228550; rania.elfarrash@med.asu.edu.eg

Marwa Adel, Assoc Prof

CONTACT

01006383120

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 2 groups 50 neonates / group

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: January 8, 2024
• Study Start: May 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)