Neonatal SepsisNCT07421323
Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection
A study testing Alcohol hand rub group and Chlorhexidine hand rub in people with Neonatal Sepsis, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 hours to 1 day
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Alcohol hand rub group and Chlorhexidine hand rub
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 hours to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates <37 weeks gestational age admitted to NICU of Alexandria University Children's Hospitals
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Marwa Mohamed Farag
Alexandria, 0325
Marwa M Farag, 01143193333, d.marwa.farag@gmail.com
Hoda Ewiss, MD, h_soliman20110@alexmed.edu.eg
About this study
Official title: a Comparison Between Effect of Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection
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.
- Conditions
- Neonatal Sepsis
- Being tested
- Alcohol hand rub group, Chlorhexidine hand rub
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol hand rub groupDrug
Medical staff used alcohol in hand rubs before contacting the neonates during their hospital stay.
Chlorhexidine hand rubDrug
Medical staff used Chlorhexidine in hand rubs before contacting the neonates during their hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol hand rub | Active comparator | Medical staff used chlorhexidine in hand rubs before contacting the neonates during their hospital stay. Receives: 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. Receives: Drug: Chlorhexidine hand rub |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood culture
having blood culture from studied groups on day 7, 14, and 28 after birth.
Measured: first month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421323
- Sponsor's protocol ID
- 010820
- Status last verified
- Aug 2025
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Comparison Between Effect of Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection
- ClinicalTrials.gov ID
- NCT07421323
- Acronym / sponsor ID
- 010820
- Conditions
- Neonatal Sepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol hand rub | Active comparator | Drug: Alcohol hand rub groupMedical staff used chlorhexidine in hand rubs before contacting the neonates during their hospital stay. |
| chlorohexidine hand rub | Active comparator | Drug: Chlorhexidine hand rubMedical staff used alcohol in hand rubs before contacting the neonates during their hospital stay. |
Who may qualify
- Ages
- 6 hours to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates <37 weeks gestational age admitted to NICU of Alexandria University Children's Hospitals
Key exclusion criteria (5 listed)
- Patients with any of the following will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol hand rub groupMedical staff used alcohol in hand rubs before contacting the neonates during their hospital stay. | Drug | Alcohol hand rub |
| Chlorhexidine hand rubMedical staff used Chlorhexidine in hand rubs before contacting the neonates during their hospital stay. | Drug | chlorohexidine hand rub |
Primary outcome
blood culture
Time frame: first month of life
having blood culture from studied groups on day 7, 14, and 28 after birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol hand rub group and Chlorhexidine hand rub in people with Neonatal Sepsis, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood culture (time frame: first month of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.