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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infection

Intervention / Treatment
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* Drug: Chlorhexidine 4.0%
* Behavioral: Dry Cord Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in parent chlorhexidine cleansing trial Exclusion Criteria: Not enrolled in parent trial First visited after 48 hours of life

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Chlorhexidine cleansing of the cord for seven days | Drug: Chlorhexidine 4.0%<br>* Solution (4.0%, 7.1% CHX-D)<br>|
| Experimental: B<br>Chlorhexidine cleansing of the cord for 1 day | Drug: Chlorhexidine 4.0%<br>* Solution (4.0%, 7.1% CHX-D)<br>|
| Placebo Comparator: C<br>Dry cord care, as recommended by WHO | Behavioral: Dry Cord Care<br>* Educational messages regarding clean cord care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Colonization at Day 3 Swab | Were any organisms found on the swab collected on at Day 03 | First Week of Life | 
| Colonization at Day 7 Swab | Were any organisms found on the swab collected on the day 07 visit? | First Week of Life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlorhexidine, umbilical cord