Bacterial InfectionPhase 1/2NNIPS-SFSNCT00271440
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
A Phase 1/2 study testing skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) in people with Bacterial Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
Trial summary
The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal. Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteNepal
- Study dates
- Jan 2006to Apr 2006
- Phase
- Phase 1/2
- 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 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- babies born at Tribhuvan University Teaching Hospital
- greater than 1500 grams
Who cannot join
- less than 1500 grams
- requires major surgical procedure
- clinically evident skin infection
- generalized skin disease
- major congenital anomoly
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.
Read the detailed description
Studies in Malawi, Egypt, and Nepal suggest that neonatal skin cleansing with chlorhexidine solutions may reduce the risk of infection and mortality. Cleansing with 0.25% chlorhexidine in Nepal resulted in a 28% reduction in mortality among low birth weight infants, while there was no impact on infants of normal weight. The mechanism of action for this observed benefit is not clear. Chlorhexidine may remove pathogens from the skin of the newborn and/or prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. The benefit of chlorhexidine cleansing may be extended with higher concentrations of chlorhexidine.
Infants born at the Tribhuvan University Teaching Hospital in Katmandu, Nepal will be randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%, 0.50%, 1.00%). Skin swabs will be collected before wiping, and two and twenty-four hours after wiping in order to compare levels of bacteria on the skin across the treatment groups. A small quantity of blood will be collected at 24 hours after wiping to determine the potential for absorption of chlorhexidine
- Conditions
- Bacterial Infection
- Being tested
- skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
- Keywords
- chlorhexidine, neonatal, skin flora, skin cleansing, bacterial colonization
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CHX 1.0% | Experimental | 1.0% CHX wiping Receives: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) |
| CHX 0.5% | Experimental | 0.5% Chlorhexidine Receives: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) |
| CHX 0.25% | Experimental | chlorhexidine cleansing with pre-soaked pre-sealed wipe Receives: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin flora reduction across treatment groups
Measured: prior to wipe, 2hrs after, and 24hrs after
Secondary outcomes (1)
Serum concentrations of chlorhexidine 24 hours after wipe
Measured: 24 hrs after wipe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University, Nepal, Nepal Nutrition Intervention Project Sarlahi
- Investigators
- Luke C Mullany, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271440
- Sponsor's protocol ID
- R01-HD44004-2
- Other IDs
- R01HD044004
- Acronym
- NNIPS-SFS
- Status last verified
- Apr 2010
- First submitted
- 29 Dec 2005
- Last updated
- 5 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
- ClinicalTrials.gov ID
- NCT00271440
- Acronym / sponsor ID
- NNIPS-SFS / R01-HD44004-2
- Conditions
- Bacterial Infection
- Keywords
- chlorhexidine, neonatal, skin flora, skin cleansing, bacterial colonization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Tribhuvan University, Nepal, Nepal Nutrition Intervention Project Sarlahi
- Study start
- Jan 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 2 Jan 2006 (estimated)
- 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.
The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.
Detailed description
Studies in Malawi, Egypt, and Nepal suggest that neonatal skin cleansing with chlorhexidine solutions may reduce the risk of infection and mortality. Cleansing with 0.25% chlorhexidine in Nepal resulted in a 28% reduction in mortality among low birth weight infants, while there was no impact on infants of normal weight. The mechanism of action for this observed benefit is not clear. Chlorhexidine may remove pathogens from the skin of the newborn and/or prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. The benefit of chlorhexidine cleansing may be extended with higher concentrations of chlorhexidine.
Infants born at the Tribhuvan University Teaching Hospital in Katmandu, Nepal will be randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%, 0.50%, 1.00%). Skin swabs will be collected before wiping, and two and twenty-four hours after wiping in order to compare levels of bacteria on the skin across the treatment groups. A small quantity of blood will be collected at 24 hours after wiping to determine the potential for absorption of chlorhexidine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHX 1.0% | Experimental | Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)1.0% CHX wiping |
| CHX 0.5% | Experimental | Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)0.5% Chlorhexidine |
| CHX 0.25% | Experimental | Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)chlorhexidine cleansing with pre-soaked pre-sealed wipe |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- babies born at Tribhuvan University Teaching Hospital
- greater than 1500 grams
Key exclusion criteria (5 listed)
- less than 1500 grams
- requires major surgical procedure
- clinically evident skin infection
- generalized skin disease
- major congenital anomoly
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 |
|---|---|---|
| skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) | Procedure or surgery | CHX 0.25%, CHX 0.5%, CHX 1.0% |
Primary outcome
Skin flora reduction across treatment groups
Time frame: prior to wipe, 2hrs after, and 24hrs after
1 secondary outcome
Serum concentrations of chlorhexidine 24 hours after wipe
Time frame: 24 hrs after wipe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2010.
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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.
Luke C Mullany, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) in people with Bacterial Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
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 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: finished, as of the sponsor's last update on 5 Apr 2010. 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 Nepal. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin flora reduction across treatment groups (time frame: prior to wipe, 2hrs after, and 24hrs after). 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 5 Apr 2010.