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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Infection

Treatments: Drug: Chlorhexidine 4.0%; Behavioral: Dry Cord Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00719329

THRASHER-02827-0

Details and patient eligibility

About

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.

Enrollment: 1,931 patients

Sex: All

Ages: Under 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Enrolled in parent chlorhexidine cleansing trial

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,931 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Chlorhexidine cleansing of the cord for seven days

Treatment:

Drug: Chlorhexidine 4.0%

B

Experimental group

Description:

Chlorhexidine cleansing of the cord for 1 day

Treatment:

Drug: Chlorhexidine 4.0%

C

Placebo Comparator group

Description:

Dry cord care, as recommended by WHO

Treatment:

Behavioral: Dry Cord Care