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NCT00719329 · ClinicalTrials.gov registry record · NA
Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh
A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- NA
- Development phase
- 1,931
- Enrollment target
NCT00719329: Completed NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT00719329 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 1,931 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719329, a NA study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,931 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Chlorhexidine 4.0%
- BEHAVIORAL Dry Cord Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,931 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-09 |
| Phase | NA |
What the finished NCT00719329 record still lists
NCT00719329 is an interventional study that assigns participants to a tested intervention. Its 1,931 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Chlorhexidine 4.0% is the first listed.
NCT00719329 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00719329 about?
NCT00719329 is a clinical study titled "Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh". 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, howev...
What is the current status of trial NCT00719329?
This trial is currently completed. It is a NA study. The enrollment target is 1,931 participants. The study started on 2008-08. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00719329?
The interventions under investigation include: Chlorhexidine 4.0% (DRUG), Dry Cord Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT00719329?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00719329's enrollment target sits among peer trials
1,931 55th of 2000 higher than 1,946 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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