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| Name | Class |
|---|---|
| Dhaka Shishu Hospital | OTHER |
| Shimantik, Bangladesh | UNKNOWN |
| Thrasher Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Chlorhexidine cleansing of the cord for seven days |
|
| B | Experimental | Chlorhexidine cleansing of the cord for 1 day |
|
| C | Placebo Comparator | Dry cord care, as recommended by WHO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine 4.0% | Drug | Solution (4.0%, 7.1% CHX-D) |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke C Mullany, PhD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States | ||
| Projahnmo |
Babies were allocated based on their cluster allocation (i.e. location of birth) in the parent trial
All babies recruited between September 2008 and September 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | CHX Cleansing - 7 Days | Chlorhexidine cleansing of the cord for seven days |
| FG001 | CHX Cleansing - 1 Day | Chlorhexidine cleansing of the cord for 1 day |
| FG002 | Dry Cord Care | Dry cord care, as recommended by WHO |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CHX Cleansing - 7 Days | Chlorhexidine cleansing of the cord for seven days |
| BG001 | CHX Cleansing - 1 Day | Chlorhexidine cleansing of the cord for 1 day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to Treat | Posted | Number | Participants | First week of life |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHX Cleansing - 7 Days | Chlorhexidine cleansing of the cord for seven days |
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Not all possible swab data were available for each baby due to staff leave/holiday, unplanned work stoppage, child/mother absent/moved/died, swab collected but not processed - these reasons did not differ between the groups
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Luke Mullany | Johns Hopkins Bloomberg School of Public Health | 410-502-2626 | lmullany@jhsph.edu |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Dry Cord Care |
| Behavioral |
Educational messages regarding clean cord care |
|
| Sylhet |
| Sylhet Division |
| Bangladesh |
| Dhaka Shishu Hospital | Dhaka | Bangladesh |
| BG002 | Dry Cord Care | Dry cord care, as recommended by WHO |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Dry Cord Care |
Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord |
|
|
|
| Primary | Colonization at Day 3 Swab | Were any organisms found on the swab collected on at Day 03 | Intent to Treat | Posted | Number | Participants | First Week of Life |
|
|
|
|
| Primary | Colonization at Day 7 Swab | Were any organisms found on the swab collected on the day 07 visit? | Intent to Treat | Posted | Number | Participants | First Week of Life |
|
|
|
|
| 0 |
| 705 |
| 0 |
| 705 |
| EG001 | CHX Cleansing - 1 Day | Chlorhexidine cleansing of the cord for 1 day | 0 | 571 | 0 | 571 |
| EG002 | Dry Cord Care | Dry cord care, as recommended by WHO | 0 | 647 | 0 | 647 |
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|
Comparison of colonization prevalence, relative to dry cord care group |
| Binomial Regression, Log Link |
Generalized Estimating Equations to account for clustered allocation |
| Prevalence Rate Ratio |
| 0.61 |
| 2-Sided |
| 95 |
| 0.57 |
| 0.65 |
Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care |
| No |
| Superiority or Other |
|
Comparison of colonization prevalence, relative to dry cord care group |
| Binomial Regression, Log Link |
General Estimating Equations to account for clustered allocation |
| Prevalence Rate Ratio |
| 0.57 |
| 2-Sided |
| 95 |
| 0.53 |
| 0.63 |
Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care |
| No |
| Superiority or Other |