Infection
Conditions
Keywords
chlorhexidine, umbilical cord
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.
Interventions
DRUGChlorhexidine 4.0%
Solution (4.0%, 7.1% CHX-D)
BEHAVIORALDry Cord Care
Educational messages regarding clean cord care
Sponsors
Dhaka Shishu Hospital
Shimantik, Bangladesh
Thrasher Research Fund
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
Yes
Inclusion criteria
* Enrolled in parent chlorhexidine cleansing trial
Exclusion criteria
* Not enrolled in parent trial * First visited after 48 hours of life
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonization at Day 1 Swab | 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. |
| Colonization at Day 3 Swab | First Week of Life | Were any organisms found on the swab collected on at Day 03 |
| Colonization at Day 7 Swab | First Week of Life | Were any organisms found on the swab collected on the day 07 visit? |
Countries
Bangladesh, United States
Participant flow
Recruitment details
All babies recruited between September 2008 and September 2009
Pre-assignment details
Babies were allocated based on their cluster allocation (i.e. location of birth) in the parent trial
Participants by arm
| Arm | Count |
|---|---|
| CHX Cleansing - 7 Days Chlorhexidine cleansing of the cord for seven days | 705 |
| CHX Cleansing - 1 Day Chlorhexidine cleansing of the cord for 1 day | 571 |
| Dry Cord Care Dry cord care, as recommended by WHO | 647 |
| Total | 1,923 |
Baseline characteristics
| Characteristic | CHX Cleansing - 7 Days | CHX Cleansing - 1 Day | Dry Cord Care | Total |
|---|---|---|---|---|
| Age, Customized [0, 6) Hours | 464 Participants | 350 Participants | 425 Participants | 1239 Participants |
| Age, Customized [12, 24) Hours | 84 Participants | 72 Participants | 86 Participants | 242 Participants |
| Age, Customized >=24 Hours | 43 Participants | 45 Participants | 30 Participants | 118 Participants |
| Age, Customized [6, 12) Hours | 114 Participants | 104 Participants | 106 Participants | 324 Participants |
| Sex: Female, Male Female | 339 Participants | 292 Participants | 316 Participants | 947 Participants |
| Sex: Female, Male Male | 366 Participants | 279 Participants | 331 Participants | 976 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 705 | 0 / 571 | 0 / 647 |
| serious Total, serious adverse events | 0 / 705 | 0 / 571 | 0 / 647 |
Outcome results
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.
Time frame: First week of life
Population: Intention to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHX Cleansing - 7 Days | Colonization at Day 1 Swab | Positive - one or more organisms found | 466 Participants |
| CHX Cleansing - 7 Days | Colonization at Day 1 Swab | Negative - no organisms found | 239 Participants |
| CHX Cleansing - 1 Day | Colonization at Day 1 Swab | Positive - one or more organisms found | 396 Participants |
| CHX Cleansing - 1 Day | Colonization at Day 1 Swab | Negative - no organisms found | 173 Participants |
| Dry Cord Care | Colonization at Day 1 Swab | Positive - one or more organisms found | 605 Participants |
| Dry Cord Care | Colonization at Day 1 Swab | Negative - no organisms found | 41 Participants |
Comparison: Comparison of colonization prevalence, relative to dry cord care group95% CI: [0.7, 0.81]Binomial Regression, Log Link
Comparison: Comparison of colonization prevalence, relative to dry cord care group95% CI: [0.66, 0.77]Binomial Regression, Log Link
Primary
Colonization at Day 3 Swab
Were any organisms found on the swab collected on at Day 03
Time frame: First Week of Life
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHX Cleansing - 7 Days | Colonization at Day 3 Swab | Positive for any organisms | 363 Participants |
| CHX Cleansing - 7 Days | Colonization at Day 3 Swab | Negative for any organisms | 251 Participants |
| CHX Cleansing - 1 Day | Colonization at Day 3 Swab | Positive for any organisms | 381 Participants |
| CHX Cleansing - 1 Day | Colonization at Day 3 Swab | Negative for any organisms | 120 Participants |
| Dry Cord Care | Colonization at Day 3 Swab | Positive for any organisms | 563 Participants |
| Dry Cord Care | Colonization at Day 3 Swab | Negative for any organisms | 15 Participants |
Comparison: Comparison of colonization prevalence, relative to dry cord care group95% CI: [0.74, 0.82]Binomial Regression, Log Link
Comparison: Comparison of colonization prevalence, relative to dry cord care group95% CI: [0.57, 0.65]Binomial Regression, Log Link
Primary
Colonization at Day 7 Swab
Were any organisms found on the swab collected on the day 07 visit?
Time frame: First Week of Life
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHX Cleansing - 7 Days | Colonization at Day 7 Swab | Negative for any organisms | 265 Participants |
| CHX Cleansing - 7 Days | Colonization at Day 7 Swab | Positive for any organisms | 328 Participants |
| CHX Cleansing - 1 Day | Colonization at Day 7 Swab | Positive for any organisms | 415 Participants |
| CHX Cleansing - 1 Day | Colonization at Day 7 Swab | Negative for any organisms | 52 Participants |
| Dry Cord Care | Colonization at Day 7 Swab | Positive for any organisms | 540 Participants |
| Dry Cord Care | Colonization at Day 7 Swab | Negative for any organisms | 21 Participants |
Comparison: Comparison of colonization prevalence, relative to dry cord care group95% CI: [0.89, 0.96]Binomial Regression, Log Link
Comparison: Comparison of colonization prevalence, relative to dry cord care group95% CI: [0.53, 0.63]Binomial Regression, Log Link