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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719329
• Other study ID #: THRASHER-02827-0
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: March 28, 2012
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1931
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

• Not enrolled in parent trial

• First visited after 48 hours of life

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Chlorhexidine 4.0%
Solution (4.0%, 7.1% CHX-D)

Behavioral:
• Dry Cord Care
Educational messages regarding clean cord care

Locations

Country	Name	City	State
Bangladesh	Dhaka Shishu Hospital	Dhaka
Bangladesh	Projahnmo	Sylhet City	Sylhet
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Dhaka Shishu Hospital, Shimantik, Bangladesh, Thrasher Research Fund

Countries where clinical trial is conducted

United States,  Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonization at Day 1 Swab	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.	First week of life	No
Primary	Colonization at Day 3 Swab	Were any organisms found on the swab collected on at Day 03	First Week of Life	No
Primary	Colonization at Day 7 Swab	Were any organisms found on the swab collected on the day 07 visit?	First Week of Life	No