Neonatal InfectionNCT06194396
Effect of Chlorhexidine Versus Alcohol on Infections in Neonates
A study testing chlorhexidine and alcohol in people with Neonatal Infection, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Infection
- What is being tested?
- chlorhexidine and alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Extremely preterm (GA less than 28 weeks).
- Babies who have an allergy to chlorhexidine 2%.
Trial locations and contacts
1 site in 1 country.
Marwa Adel, Assoc Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo, 11865
Rania El Farrash, Professor, +20122228550, rania.elfarrash@med.asu.edu.eg
Marwa Adel, Assoc Prof, 01006383120
About this study
Official title: Effect of Chlorhexidine 2% Versus Alcohol on Healthcare Associated Infections in Neonates: Randomized Control Trial
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.
Read the 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.
- Conditions
- Neonatal Infection
- Being tested
- chlorhexidine, alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidineOther
chlorhexidine will be used as skin disinfectant before insertion of CVC, PICC line, and umbilical catheter
alcoholOther
alcohol will be used as skin disinfectant before insertion of CVC ,PICC line and umbilical catheter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 May 2023
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- 2 groups 50 neonates / group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ali El-Farrash, Ain Shams University
- Investigators
- Rania El Farrash, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194396
- Sponsor's protocol ID
- FMASU
- Status last verified
- Mar 2024
- First submitted
- 4 May 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine 2% Versus Alcohol on Healthcare Associated Infections in Neonates: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06194396
- Acronym / sponsor ID
- FMASU
- Conditions
- Neonatal Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups 50 neonates / group
| Arm | Type | Receives |
|---|---|---|
| 50 neonates using alcohol | Active comparator | Other: alcoholAlcohol will be used as skin disinfectant before insertion of the central venous catheter, PICC line, and umbilical venous catheter and during its routine care |
| 50 neonates using chlorhexidine | Experimental | Other: chlorhexidineChlorhexidine 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 |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Extremely preterm (GA less than 28 weeks).
- Babies who have an allergy to chlorhexidine 2%.
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 |
|---|---|---|
| chlorhexidinechlorhexidine will be used as skin disinfectant before insertion of CVC, PICC line, and umbilical catheter | Other | 50 neonates using chlorhexidine |
| alcoholalcohol will be used as skin disinfectant before insertion of CVC ,PICC line and umbilical catheter | Other | 50 neonates using alcohol |
Primary outcome
reduction in health care acquired neonatal infection
Time frame: 8 months
to determine whether the use of chlorhexidine 2% solution reduces the health care-acquired neonatal infection when compared to alcohol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marwa Adel, Assoc Prof contact
Rania El Farrash principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chlorhexidine and alcohol in people with Neonatal Infection, run by Ain Shams 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania A El Farrash, Professor (+20122228550, rania.elfarrash@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in health care acquired neonatal infection (time frame: 8 months). 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 12 Mar 2024.