NCT07421323

Brief Summary

This study aims to compare of effect of chlorhexidine gluconate and alcohol hand rubbing on healthcare-associated infection (HCAI) in neonatal intensive care unit at Alexandria University Children Hospital.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 19, 2026

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

  • blood culture

    having blood culture from studied groups on day 7, 14, and 28 after birth.

    first month of life

Study Arms (2)

Alcohol hand rub

ACTIVE COMPARATOR

Medical staff used chlorhexidine in hand rubs before contacting the neonates during their hospital stay.

Drug: Alcohol hand rub group

chlorohexidine hand rub

ACTIVE COMPARATOR

Medical staff used alcohol in hand rubs before contacting the neonates during their hospital stay.

Drug: Chlorhexidine hand rub

Interventions

Alcohol hand rub groupDRUG

Medical staff used alcohol in hand rubs before contacting the neonates during their hospital stay.

Alcohol hand rub
Chlorhexidine hand rubDRUG

Medical staff used Chlorhexidine in hand rubs before contacting the neonates during their hospital stay.

chlorohexidine hand rub

Eligibility Criteria

Age6 Hours - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates \<37 weeks gestational age admitted to NICU of Alexandria University Children's Hospitals

You may not qualify if:

  • Patients with any of the following will be excluded:
  • Obvious major congenital abnormalities, immunodeficiency and inborn error of metabolism.
  • Early onset sepsis (before the third day).
  • Infants more than 72 hours of age at the time of randomization.
  • Parental consent lacking/refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0325, Egypt

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

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
Assistant professor of Pediatrics

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

August 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 19, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)