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

Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection

Intervention: Chlorhexidine 4.0% (Drug); Dry Cord Care (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Luke C Mullany, PhD, Study Director, Affiliation: Johns Hopkins School of Public Health

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.

Clinical Details

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

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

Primary outcome:

Colonization at Day 1 Swab

Colonization at Day 3 Swab

Colonization at Day 7 Swab

Eligibility

Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

- Not enrolled in parent trial

- First visited after 48 hours of life

Locations and Contacts

Dhaka Shishu Hospital, Dhaka, Bangladesh

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205, United States

Projahnmo, Sylhet City, Sylhet, Bangladesh

Additional Information

Starting date: August 2008
Last updated: March 28, 2012

Page last updated: August 23, 2015

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