Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh

Not Applicable

Completed

• Conditions: Infection
• Interventions: Drug: Chlorhexidine 4.0%; Behavioral: Dry Cord Care

• Registration Number: NCT00719329
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Study Start: 2008-08
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-08-10
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-28
• Last Update Submitted: 2012-03-28
• Results First Posted: 2012-04-20
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1931

Inclusion Criteria

• Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria

• Not enrolled in parent trial
• First visited after 48 hours of life

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Chlorhexidine 4.0%	Chlorhexidine cleansing of the cord for seven days
B	Chlorhexidine 4.0%	Chlorhexidine cleansing of the cord for 1 day
C	Dry Cord Care	Dry cord care, as recommended by WHO

Primary Outcome Measures

Name	Time	Method
Colonization at Day 1 Swab	First week of life	Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.
Colonization at Day 3 Swab	First Week of Life	Were any organisms found on the swab collected on at Day 03
Colonization at Day 7 Swab	First Week of Life	Were any organisms found on the swab collected on the day 07 visit?

Trial Locations

Locations (3)

Projahnmo; 🇧🇩 Sylhet City, Sylhet, Bangladesh

Dhaka Shishu Hospital; 🇧🇩 Dhaka, Bangladesh

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States