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

NCT ID: NCT00719329

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1931 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-09-30

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.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Chlorhexidine cleansing of the cord for seven days

Group Type: EXPERIMENTAL

Chlorhexidine 4.0%

Intervention Type: DRUG

Solution (4.0%, 7.1% CHX-D)

B

Chlorhexidine cleansing of the cord for 1 day

Group Type: EXPERIMENTAL

Chlorhexidine 4.0%

Intervention Type: DRUG

Solution (4.0%, 7.1% CHX-D)

C

Dry cord care, as recommended by WHO

Group Type: PLACEBO_COMPARATOR

Dry Cord Care

Intervention Type: BEHAVIORAL

Educational messages regarding clean cord care

Interventions

Chlorhexidine 4.0%

Solution (4.0%, 7.1% CHX-D)

Intervention Type: DRUG

Dry Cord Care

Educational messages regarding clean cord care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria

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

• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dhaka Shishu Hospital

OTHER

Sponsor Role: collaborator

Shimantik, Bangladesh

UNKNOWN

Sponsor Role: collaborator

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Luke C. Mullany

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luke C Mullany, PhD

Role: STUDY_DIRECTOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Projahnmo

Sylhet, Sylhet Division, Bangladesh

Dhaka Shishu Hospital

Dhaka, , Bangladesh

Countries

United States; Bangladesh

Other Identifiers

THRASHER-02827-0

Identifier Type: -

Identifier Source: org_study_id