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

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

Sponsors

Lead sponsor: Johns Hopkins Bloomberg School of Public Health

Collaborator: Dhaka Shishu Hospital
Shimantik, Bangladesh
Thrasher Research Fund

Source 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.

Overall Status Completed
Start Date August 2008
Completion Date September 2009
Primary Completion Date September 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Colonization at Day 1 Swab First week of life
Colonization at Day 3 Swab First Week of Life
Colonization at Day 7 Swab First Week of Life
Enrollment 1931
Condition
Intervention

Intervention type: Drug

Intervention name: Chlorhexidine 4.0%

Description: Solution (4.0%, 7.1% CHX-D)

Intervention type: Behavioral

Intervention name: Dry Cord Care

Description: Educational messages regarding clean cord care

Arm group label: C

Eligibility

Criteria:

Inclusion Criteria:

- Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

- Not enrolled in parent trial

- First visited after 48 hours of life

Gender: All

Minimum age: N/A

Maximum age: 7 Days

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Luke C Mullany, PhD Study Director Johns Hopkins Bloomberg School of Public Health
Location
facility
Johns Hopkins Bloomberg School of Public Health | Baltimore, Maryland, 21205, United States
Projahnmo | Sylhet City, Sylhet, Bangladesh
Dhaka Shishu Hospital | Dhaka, Bangladesh
Location Countries

Bangladesh

United States

Verification Date

March 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Johns Hopkins Bloomberg School of Public Health

Investigator full name: Luke C. Mullany

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: A

Arm group type: Experimental

Description: Chlorhexidine cleansing of the cord for seven days

Arm group label: B

Arm group type: Experimental

Description: Chlorhexidine cleansing of the cord for 1 day

Arm group label: C

Arm group type: Placebo Comparator

Description: Dry cord care, as recommended by WHO

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov