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

April 2, 2010 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

286

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Tribhuvan University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
Experimental: CHX 0.5%
0.5% Chlorhexidine
Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
Experimental: CHX 0.25%
chlorhexidine cleansing with pre-soaked pre-sealed wipe
Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

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

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Tribhuvan University, Nepal
Nepal Nutrition Intervention Project Sarlahi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

December 29, 2005

First Submitted That Met QC Criteria

December 29, 2005

First Posted (Estimate)

January 2, 2006

Study Record Updates

Last Update Posted (Estimate)

April 5, 2010

Last Update Submitted That Met QC Criteria

April 2, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

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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