Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh
Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: Chlorhexidine 4.0% (Drug); Dry Cord Care (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Johns Hopkins Bloomberg School of Public Health Official(s) and/or principal investigator(s): Luke C Mullany, PhD, Study Director, Affiliation: Johns Hopkins School of Public Health
Summary
Background: In developing countries, many babies are born at home and the umbilical cord
commonly becomes infected during the first week after birth, and can be deadly. Cleansing
of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these
infections. Little is known, however, about the frequency of chlorhexidine cleansing needed
to impact upon the overall presence of bacteria on the stump, or regarding the changes in
bacteria during the first week of life when most cord infections occur.
Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of
infants in rural Bangladesh and examine the role of topical chlorhexidine in altering
colonization and progress of infection. We will compare the overall and bacteria-specific
rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of
their cord through the first day or first week of life. We will also quantify the
relationship between colonization of the cord stump with specific pathogens and the presence
and severity of signs of umbilical cord infection (pus, redness, swelling) among these
newborns.
Potential Impact: More information is needed on the impact of single versus repeated
applications of chlorhexidine to the cord stump, as the number of cleansing may
substantially influence the feasibility of widespread scale-up in many populations. The
data generated from this proposed study will guide the most appropriate design of this
simple intervention and will help inform specific treatment protocols for effective
management of infants with signs of umbilical cord infections.
Clinical Details
Official title: Bacterial Colonization of the Neonatal Umbilical Cord and Impact of 4.0% Chlorhexidine Cleansing on the Bacteriological Profile of the Umbilical Cord of Newborns in Sylhet District, Bangladesh
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Colonization at Day 1 SwabColonization at Day 3 Swab Colonization at Day 7 Swab
Eligibility
Minimum age: N/A.
Maximum age: 7 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Enrolled in parent chlorhexidine cleansing trial
Exclusion Criteria:
- Not enrolled in parent trial
- First visited after 48 hours of life
Locations and Contacts
Dhaka Shishu Hospital, Dhaka, Bangladesh
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205, United States
Projahnmo, Sylhet City, Sylhet, Bangladesh
Additional Information
Starting date: August 2008
Last updated: March 28, 2012
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