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N/A N=1,923 Randomized Prevention

Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh

Infection

Enrolled (actual)
1,923
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Colonization at Day 1 Swab — 466; 396; 605; 239 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Chlorhexidine 4.0% (Drug); Dry Cord Care (Behavioral)
Age
Pediatric
Sex
All
Sponsor
Johns Hopkins Bloomberg School of Public Health
Primary completion
Sep 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Colonization at Day 1 Swab
466; 396; 605; 239; 173; 41
PRIMARY
Colonization at Day 3 Swab
363; 381; 563; 251; 120; 15
PRIMARY
Colonization at Day 7 Swab
328; 415; 540; 265; 52; 21

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.

Eligibility Criteria

Inclusion Criteria

  • Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria

  • Not enrolled in parent trial
  • First visited after 48 hours of life
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00719329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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