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Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal (NNIPS-SFS)

Primary Purpose

Bacterial Infection

Status
Completed
Phase
Phase 1
Locations
Nepal
Study Type
Interventional
Intervention
skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infection focused on measuring chlorhexidine, neonatal, skin flora, skin cleansing, bacterial colonization

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tribhuvan University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CHX 1.0%

CHX 0.5%

CHX 0.25%

Arm Description

1.0% CHX wiping

0.5% Chlorhexidine

chlorhexidine cleansing with pre-soaked pre-sealed wipe

Outcomes

Primary Outcome Measures

Skin flora reduction across treatment groups

Secondary Outcome Measures

Serum concentrations of chlorhexidine 24 hours after wipe

Full Information

First Posted
December 29, 2005
Last Updated
April 2, 2010
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Tribhuvan University, Nepal, Nepal Nutrition Intervention Project Sarlahi
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1. Study Identification

Unique Protocol Identification Number
NCT00271440
Brief Title
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
Acronym
NNIPS-SFS
Official Title
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Tribhuvan University, Nepal, Nepal Nutrition Intervention Project Sarlahi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection
Keywords
chlorhexidine, neonatal, skin flora, skin cleansing, bacterial colonization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHX 1.0%
Arm Type
Experimental
Arm Description
1.0% CHX wiping
Arm Title
CHX 0.5%
Arm Type
Experimental
Arm Description
0.5% Chlorhexidine
Arm Title
CHX 0.25%
Arm Type
Experimental
Arm Description
chlorhexidine cleansing with pre-soaked pre-sealed wipe
Intervention Type
Procedure
Intervention Name(s)
skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
Primary Outcome Measure Information:
Title
Skin flora reduction across treatment groups
Time Frame
prior to wipe, 2hrs after, and 24hrs after
Secondary Outcome Measure Information:
Title
Serum concentrations of chlorhexidine 24 hours after wipe
Time Frame
24 hrs after wipe

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke C Mullany, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tribhuvan University Teaching Hospital
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

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Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

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