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

This study has been completed.
Sponsor:
Collaborators:
Tribhuvan University, Nepal
Nepal Nutrition Intervention Project, Sarlahi
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00271440
First received: December 29, 2005
Last updated: April 2, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Infection
 Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Skin flora reduction across treatment groups [ Time Frame: prior to wipe, 2hrs after, and 24hrs after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum concentrations of chlorhexidine 24 hours after wipe [ Time Frame: 24 hrs after wipe ] [ Designated as safety issue: Yes ]

Enrollment: 286
Study Start Date: January 2006
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

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

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271440

Locations
Nepal
Tribhuvan University Teaching Hospital
Kathmandu, Nepal
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Tribhuvan University, Nepal
Nepal Nutrition Intervention Project, Sarlahi
Investigators
Principal Investigator: Luke C Mullany, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00271440     History of Changes
Other Study ID Numbers: R01-HD44004-2
Study First Received: December 29, 2005
Last Updated: April 2, 2010
Health Authority: United States: Institutional Review Board
Nepal: Institute of Medicine, Tribhuvan University

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
chlorhexidine
neonatal
skin flora
skin cleansing
bacterial colonization

Additional relevant MeSH terms:
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013