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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00719329
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : April 20, 2012
Last Update Posted : April 20, 2012
Sponsor:
Collaborators:
Dhaka Shishu Hospital
Shimantik, Bangladesh
Thrasher Research Fund
Information provided by (Responsible Party):
Luke C. Mullany, Johns Hopkins Bloomberg School of Public Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Infection Drug: Chlorhexidine 4.0% Behavioral: Dry Cord Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1931 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : August 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Chlorhexidine cleansing of the cord for seven days
 Drug: Chlorhexidine 4.0%
Solution (4.0%, 7.1% CHX-D)
Experimental: B
Chlorhexidine cleansing of the cord for 1 day
 Drug: Chlorhexidine 4.0%
Solution (4.0%, 7.1% CHX-D)
Placebo Comparator: C
Dry cord care, as recommended by WHO
 Behavioral: Dry Cord Care
Educational messages regarding clean cord care


Outcome Measures
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Primary Outcome Measures :
  1. Colonization at Day 1 Swab [ Time Frame: First week of life ]
    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.

  2. Colonization at Day 3 Swab [ Time Frame: First Week of Life ]
    Were any organisms found on the swab collected on at Day 03

  3. Colonization at Day 7 Swab [ Time Frame: First Week of Life ]
    Were any organisms found on the swab collected on the day 07 visit?


Eligibility Criteria
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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

  • Not enrolled in parent trial
  • First visited after 48 hours of life
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719329


Locations
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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Bangladesh
Projahnmo
Sylhet City, Sylhet, Bangladesh
Dhaka Shishu Hospital
Dhaka, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Dhaka Shishu Hospital
Shimantik, Bangladesh
Thrasher Research Fund
Investigators
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Study Director: Luke C Mullany, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Responsible Party: Luke C. Mullany, Associate Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00719329    
Other Study ID Numbers: THRASHER-02827-0
First Posted: July 21, 2008    Key Record Dates
Results First Posted: April 20, 2012
Last Update Posted: April 20, 2012
Last Verified: March 2012
Keywords provided by Luke C. Mullany, Johns Hopkins Bloomberg School of Public Health:
chlorhexidine
umbilical cord
Additional relevant MeSH terms:
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Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants