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

December 29, 2005
April 2, 2010
January 2006
April 2006   (final data collection date for primary outcome measure)
Skin flora reduction across treatment groups [ Time Frame: prior to wipe, 2hrs after, and 24hrs after ] [ Designated as safety issue: No ]
Skin flora reduction across treatment groups
Complete list of historical versions of study NCT00271440 on ClinicalTrials.gov Archive Site
Serum concentrations of chlorhexidine 24 hours after wipe [ Time Frame: 24 hrs after wipe ] [ Designated as safety issue: Yes ]
Serum concentrations of chlorhexidine 24 hours after wipe
Not Provided
Not Provided
 
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Infection
Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
  • Experimental: CHX 1.0%
    1.0% CHX wiping
    Intervention: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
  • Experimental: CHX 0.5%
    0.5% Chlorhexidine
    Intervention: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
  • Experimental: CHX 0.25%
    chlorhexidine cleansing with pre-soaked pre-sealed wipe
    Intervention: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
up to 3 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Nepal
 
NCT00271440
R01-HD44004-2
No
Not Provided
Johns Hopkins Bloomberg School of Public Health
  • Tribhuvan University, Nepal
  • Nepal Nutrition Intervention Project, Sarlahi
Principal Investigator: Luke C Mullany, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP