- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00271440
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal (NNIPS-SFS)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Kathmandu, Nepal
- Tribhuvan University Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- babies born at Tribhuvan University Teaching Hospital
- greater than 1500 grams
Exclusion Criteria:
- less than 1500 grams
- requires major surgical procedure
- clinically evident skin infection
- generalized skin disease
- major congenital anomoly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHX 1.0%
1.0% CHX wiping
|
|
Experimental: CHX 0.5%
0.5% Chlorhexidine
|
|
Experimental: CHX 0.25%
chlorhexidine cleansing with pre-soaked pre-sealed wipe
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Skin flora reduction across treatment groups
Time Frame: prior to wipe, 2hrs after, and 24hrs after
|
prior to wipe, 2hrs after, and 24hrs after
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum concentrations of chlorhexidine 24 hours after wipe
Time Frame: 24 hrs after wipe
|
24 hrs after wipe
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01-HD44004-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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