Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preventing Central Line-Associated Bloodstream Infections in Very Preterm Babies or Birth Weight <1500 Grams at Cipto Mangunkusumo Hospital Neonatology Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of Central Line Associated Bloodstream Infection (CLABSI)
研究概览
简要总结
The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams)
The main questions it aims to answer are:
- What is the incidence of Central Line-Associated Bloodstream Infections when using a split septum connector?
- What is the incidence of Central Line-Associated Bloodstream Infections when using a mechanical valve connector?
- What is the ratio length of stay between babies with birth weight < 1500 grams who use split septum connector and mechanical valve?
- What is the ratio incidence of mortality due to sepsis of babies with birth weight < 1500 grams who use split septum connector and mechanical valve?
Participants will be observed for two weeks after insertion of central line. They will be taken blood sample for culture and sepsis marker panel.
Researchers will compare split septum group and mechanical valve group to see if there is a central line associated bloodstream 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 (Participant, Investigator)
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm neonates with gestational age less than and equal to 32 weeks
- •Birth weight less than 1500 gram
- •Neonates indicated to use central line access
- •Parents are willing to participate in this study and has filled and signed the informed consent letter
排除标准
- •Neonates who are previously diagnosed as CLABSI
- •Neonates who has other focus of infection that are diagnosed before the recruitment
- •Suffer from congenital abnormalities
结局指标
主要结局
Incidence of Central Line Associated Bloodstream Infection (CLABSI)
时间窗: From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 30 days
The incidence of CLABSI are proven by clinical symptoms followed by positive blood culture taken at two different site, consist of peripheral and central site
次要结局
- Hospitalization cost(From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days)
- Length of stay(From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days)
- CLABSI-related mortality(From the date of central line insertion until the date of death, assessed up to 30 days)
- All-cause mortality(From the date of admission until the date of death, assessed up to 100 days)
- Central line days(From the date of central line insertion until the date of death, discharge, or maximum duration of 14 days, whichever comes first)
研究者
Putri Maharani Tristanita Marsubrin, MD, PhD
Neonatologist
Indonesia University