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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 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 1,931 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00719329
The ClinicalTrials.gov registry entry for NCT00719329 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,931 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Chlorhexidine 4.0% is the first listed.
NCT00719329 reports 0 study locations.
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.
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