Text Size

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00719329
First received: July 17, 2008
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Infection
 Drug: Chlorhexidine 4.0%
Behavioral: Dry Cord Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Colonization at Day 1 Swab [ Time Frame: First week of life ] [ Designated as safety issue: No ]
    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.

  • Colonization at Day 3 Swab [ Time Frame: First Week of Life ] [ Designated as safety issue: No ]
    Were any organisms found on the swab collected on at Day 03

  • Colonization at Day 7 Swab [ Time Frame: First Week of Life ] [ Designated as safety issue: No ]
    Were any organisms found on the swab collected on the day 07 visit?


Enrollment: 1931
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719329

Locations
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
Study Director: Luke C Mullany, PhD Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Luke C. Mullany, Associate Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00719329     History of Changes
Other Study ID Numbers: THRASHER-02827-0
Study First Received: July 17, 2008
Results First Received: August 10, 2011
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
chlorhexidine
umbilical cord

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013