跳至主要内容
临床试验/NCT00719329
NCT00719329已完成不适用

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

Johns Hopkins Bloomberg School of Public Health3 个研究点 分布在 2 个国家目标入组 1,931 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,931
试验地点
3
主要终点
Colonization at Day 1 Swab

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Enrolled in parent chlorhexidine cleansing trial

排除标准

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

研究组 & 干预措施

A

Experimental

Chlorhexidine cleansing of the cord for seven days

干预措施: Chlorhexidine 4.0% (Drug)

B

Experimental

Chlorhexidine cleansing of the cord for 1 day

干预措施: Chlorhexidine 4.0% (Drug)

C

Placebo Comparator

Dry cord care, as recommended by WHO

干预措施: Dry Cord Care (Behavioral)

结局指标

主要结局

Colonization at Day 1 Swab

时间窗: First week of life

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.

Colonization at Day 3 Swab

时间窗: First Week of Life

Were any organisms found on the swab collected on at Day 03

Colonization at Day 7 Swab

时间窗: First Week of Life

Were any organisms found on the swab collected on the day 07 visit?

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luke C. Mullany

Associate Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (3)

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