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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Dhaka Shishu Hospital Shimantik, Bangladesh Thrasher Research Fund |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00719329 |
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.
Condition | Intervention |
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Infection Neonates |
Drug: Chlorhexidine 4.0% Behavioral: Dry Cord Care |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 1800 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Chlorhexidine cleansing of the cord for seven days
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Drug: Chlorhexidine 4.0%
Solution (4.0%, 7.1% CHX-D)
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B: Experimental
Chlorhexidine cleansing of the cord for 1 day
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Drug: Chlorhexidine 4.0%
Solution (4.0%, 7.1% CHX-D)
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C: Placebo Comparator
Dry cord care, as recommended by WHO
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Behavioral: Dry Cord Care
Educational messages regarding clean cord care
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Ages Eligible for Study: | up to 7 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luke C Mullany, PhD | 410-502-2626 | lmullany@jhsph.edu |
United States, Maryland | |
Johns Hopkins Bloomberg School of Public Health | Not yet recruiting |
Baltimore, Maryland, United States, 21205 | |
Principal Investigator: Luke C Mullany, PhD | |
Bangladesh | |
Dhaka Shishu Hospital | Recruiting |
Dhaka, Bangladesh | |
Principal Investigator: Samir K Saha | |
Bangladesh, Sylhet | |
Projahnmo | Recruiting |
Sylhet City, Sylhet, Bangladesh |
Study Director: | Luke C Mullany, PhD | Johns Hopkins School of Public Health |
Responsible Party: | Johns Hopkins Bloomberg School of Public Health ( Luke C. Mullany, Assistant Professor ) |
Study ID Numbers: | THRASHER-02827-0 |
Study First Received: | July 17, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00719329 History of Changes |
Health Authority: | United States: Institutional Review Board |
chlorhexidine umbilical cord |
Anti-Infective Agents, Local Disinfectants Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents Anti-Infective Agents, Local Disinfectants Chlorhexidine Chlorhexidine gluconate |
Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |