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Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00271440
Acronym
NNIPS-SFS
Enrollment
286
Registered
2006-01-02
Start date
2006-01-31
Completion date
2006-04-30
Last updated
2010-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection

Keywords

chlorhexidine, neonatal, skin flora, skin cleansing, bacterial colonization

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

Interventions

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

Sponsors

Tribhuvan University, Nepal
CollaboratorOTHER
Nepal Nutrition Intervention Project Sarlahi
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Skin flora reduction across treatment groupsprior to wipe, 2hrs after, and 24hrs after

Secondary

MeasureTime frame
Serum concentrations of chlorhexidine 24 hours after wipe24 hrs after wipe

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026