Whole Body Cleansing With 0.25% Chlorhexidine at Birth for Prevention of Sepsis in Infants <1500 g: a Multi-center, Blinded, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Sepsis within first 7 days of life
研究概览
简要总结
Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing <1500 g at birth.
详细描述
Background
Infants weighing <1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. Skin application of antiseptics such as chlorhexidine may reduce infections in these infants. However, there is a paucity of data on the safety and efficacy of such intervention in these infants.
Hypothesis:
Among hospitalized very low birth weight (VLBW; <1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water
Objectives:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight less than 1500 g
排除标准
- •Birth weight <750 g
- •Major congenital malformations
- •Total duration of positive pressure ventilation (PPV) > 3 mins OR chest compressions
- •Shock- requiring inotropes >10 mic/kg/min
研究组 & 干预措施
sterile water
sterile water wipes
干预措施: sterile water (Drug)
0.25% chlorhexidine
0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine
干预措施: 0.25% chlorhexidine (Drug)
结局指标
主要结局
Sepsis within first 7 days of life
时间窗: First 7 days of life
Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.
次要结局
- Readmissions & mortality rates within neonatal period(28 days)
- Body temperature at 0, 5, 15, 30 minutes after application(30 minutes)
- Skin condition(24 ±6 hours)
- Skin colonization rates(24 ±6 hours)
- Chlorhexidine percutaneous absorption(48 ±6 hours)
研究者
Dr Vinod K Paul
Professor & Head, Department of Pediatrics
All India Institute of Medical Sciences, New Delhi