Trial Outcomes & Findings for Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh (NCT NCT00719329)
NCT ID: NCT00719329
Last Updated: 2012-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1931 participants
Primary outcome timeframe
First week of life
Results posted on
2012-04-20
Participant Flow
All babies recruited between September 2008 and September 2009
Babies were allocated based on their cluster allocation (i.e. location of birth) in the parent trial
Participant milestones
| Measure |
CHX Cleansing - 7 Days
Chlorhexidine cleansing of the cord for seven days
|
CHX Cleansing - 1 Day
Chlorhexidine cleansing of the cord for 1 day
|
Dry Cord Care
Dry cord care, as recommended by WHO
|
|---|---|---|---|
|
Overall Study
STARTED
|
705
|
571
|
647
|
|
Overall Study
Day 1 Swab
|
705
|
569
|
646
|
|
Overall Study
Day 3 Swab
|
614
|
501
|
578
|
|
Overall Study
Day 7 Swab
|
593
|
467
|
561
|
|
Overall Study
COMPLETED
|
705
|
569
|
646
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh
Baseline characteristics by cohort
| Measure |
CHX Cleansing - 7 Days
n=705 Participants
Chlorhexidine cleansing of the cord for seven days
|
CHX Cleansing - 1 Day
n=571 Participants
Chlorhexidine cleansing of the cord for 1 day
|
Dry Cord Care
n=647 Participants
Dry cord care, as recommended by WHO
|
Total
n=1923 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
[0, 6) Hours
|
464 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
425 Participants
n=5 Participants
|
1239 Participants
n=4 Participants
|
|
Age, Customized
[6, 12) Hours
|
114 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Age, Customized
[12, 24) Hours
|
84 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Age, Customized
>=24 Hours
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
339 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
947 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
366 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
976 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: First week of lifePopulation: Intention to Treat
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.
Outcome measures
| Measure |
CHX Cleansing - 7 Days
n=705 Participants
Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
|
CHX Cleansing - 1 Day
n=569 Participants
Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
|
Dry Cord Care
n=646 Participants
Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
|
|---|---|---|---|
|
Colonization at Day 1 Swab
Positive - one or more organisms found
|
466 Participants
|
396 Participants
|
605 Participants
|
|
Colonization at Day 1 Swab
Negative - no organisms found
|
239 Participants
|
173 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: First Week of LifePopulation: Intent to Treat
Were any organisms found on the swab collected on at Day 03
Outcome measures
| Measure |
CHX Cleansing - 7 Days
n=614 Participants
Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
|
CHX Cleansing - 1 Day
n=501 Participants
Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
|
Dry Cord Care
n=578 Participants
Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
|
|---|---|---|---|
|
Colonization at Day 3 Swab
Positive for any organisms
|
363 Participants
|
381 Participants
|
563 Participants
|
|
Colonization at Day 3 Swab
Negative for any organisms
|
251 Participants
|
120 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: First Week of LifePopulation: Intent to Treat
Were any organisms found on the swab collected on the day 07 visit?
Outcome measures
| Measure |
CHX Cleansing - 7 Days
n=593 Participants
Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
|
CHX Cleansing - 1 Day
n=467 Participants
Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
|
Dry Cord Care
n=561 Participants
Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
|
|---|---|---|---|
|
Colonization at Day 7 Swab
Positive for any organisms
|
328 Participants
|
415 Participants
|
540 Participants
|
|
Colonization at Day 7 Swab
Negative for any organisms
|
265 Participants
|
52 Participants
|
21 Participants
|
Adverse Events
CHX Cleansing - 7 Days
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHX Cleansing - 1 Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dry Cord Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Luke Mullany
Johns Hopkins Bloomberg School of Public Health
Phone: 410-502-2626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place