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
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
- 是
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
Chlorhexidine cleansing of the cord for seven days
干预措施: Chlorhexidine 4.0% (Drug)
B
Chlorhexidine cleansing of the cord for 1 day
干预措施: Chlorhexidine 4.0% (Drug)
C
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
Luke C. Mullany
Associate Professor
Johns Hopkins Bloomberg School of Public Health
