Overview

This trial is active, not recruiting.

Condition skin diseases, infectious
Treatment chlorhexidine
Phase phase 4
Sponsor Johns Hopkins Bloomberg School of Public Health
Start date March 2004
End date March 2005
Trial size 210 participants
Trial identifier NCT00198679, H.22.03.10.07.A2

Summary

Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.
time frame:

Eligibility Criteria

Male or female participants up to 48 hours old.

Inclusion Criteria: - Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age - parental consent must be obtained Exclusion Criteria: - infants being admitted for major surgical procedure which is attended by high rate of infectious complications - sepsis - clinically-evident skin infection - generalized skin disease - structural defect of the skin involving greater than 5% of the body surface - with a major congenital anomaly - with a known immunodeficiency

Additional Information

Official title Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh
Principal investigator Gary Darmstadt, MD
Description This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh.
Trial information was received from ClinicalTrials.gov and was last updated in May 2006.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.