Clinical trial NCT00719329: Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh
Official title: Bacterial Colonization of the Neonatal Umbilical Cord and Impact of 4.0% Chlorhexidine Cleansing on the Bacteriological Profile of the Umbilical Cord of Newborns in Sylhet District, Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: chlorhexidine
umbilical cord
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Dhaka Shishu Hospital
name: Shimantik, Bangladesh
name: Thrasher Research Fund
First posted: 2008-07-21
Enrollment: 1931
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

* Not enrolled in parent trial
* First visited after 48 hours of life

Primary outcomes:
measure: Colonization at Day 1 Swab
timeFrame: First week of life
measure: Colonization at Day 3 Swab
timeFrame: First Week of Life
measure: Colonization at Day 7 Swab
timeFrame: First Week of Life
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
city: Sylhet City
country: Bangladesh
facility: Projahnmo
state: Sylhet
city: Dhaka
country: Bangladesh
facility: Dhaka Shishu Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Luke C Mullany, PhD
role: STUDY_DIRECTOR
References: