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Completed

NCT Number: NCT00271440

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.

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tribhuvan University Teaching Hospital

Kathmandu, Nepal

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

Procedure

Primary outcomes

  1. Skin flora reduction across treatment groups

    Time frame: prior to wipe, 2hrs after, and 24hrs after

Secondary outcomes

  1. Serum concentrations of chlorhexidine 24 hours after wipe

    Time frame: 24 hrs after wipe

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Nepal Nutrition Intervention Project Sarlahi
  • Tribhuvan University, Nepal

Registry information

Acronym: NNIPS-SFS

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 2, 2006
Registry last updated
Apr 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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