A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of participants with Omphalitis
研究概览
简要总结
Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection. Topical treatment can help to reduce the chances of infection as well as increase the chances of early removal. In this regard methylated spirit and chlorhexidine are found to be effective.
Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit in newborns for prevention of omphalitis and neonatal sepsis.
Materials and Methods: This randomized control trial was carried out in neonatal unit of Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated spirit was used. Neonates were followed till 10th day of life. Careful examination was done for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.
详细描述
Introduction:
Neonatal sepsis in one of the leading causes of death in neonates in developing countries. Infection of the umbilical cord often leads to infection in the blood. World Health Organization (WHO) recommends 4% chlorhexidine to prevent omphalitis and neonatal sepsis. In Pakistan the investigators use methylated spirit for prophylaxis of omphalitis as 4% chlorhexidine is not available and expensive to use. Some commercial gels containing 2% chlorhexidine is available, but these are not as effective as methylated spirit.
Chlorhexidine gel is an antiseptic agent with broad-spectrum bactericidal and bacteriostatic properties effective against gram-negative bacteria and fungi with rapid pathogen killing rates. Methylated spirit on the other hand is both bactericidal, mycobactericidal, fungicidal, and viricidal agent.
In Pakistan Staphylococcal aureus is common pathogen in umbilical discharge. Some low cost prevention therapy should be used. Methylated spirit is commonly used for cord care. A study was conducted to explore about cord care practices in African setting which showed that 73.2% respondents consider methylated spirit as most important agent for cord care.
Chlorhexidine is available in different concentrations for antiseptic purpose. Efficacy of all concentrations is comparable but 4% chlorhexidine concentration is more effective in inhibiting organism's flora as compared to 2% chlorhexidine. Since then, multiple studies were done to compare between methylated spirit and 4% chlorhexidine. Methylated spirit is equally safe where 4% chlorhexidine is unavailable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term neonates of either gender born via cesarean section or spontaneous vaginal delivery at Shaikh Zayed Hospital after taking informed consent of parents.
- •Antiseptic agent started from 1st day of life & up to 10 days continued without missing dose
排除标准
- •Newborns with congenital defects or cord anomalies.
- •Laboratory or clinical evidence of sepsis.
- •Preterm newborns
- •Newborns having very low birth weight <1.5 kg
- •Any evidence of asphyxia during birth.
研究组 & 干预措施
Umbilical Cord Care with Chlorhexidine (Group A)
干预措施: Chlorhexidine Topical Cream (Drug)
Umbilical Cord Care with Methylated Spirit (Group B)
干预措施: Methylated Spirit (Drug)
结局指标
主要结局
Number of participants with Omphalitis
时间窗: 10 days
Inflammation of the navel in newborn babies as assessed by redness and swelling of the area.
次要结局
- Number of participants with Neonatal Sepsis(10 days)
研究者
Ahmad Zunair Wasim
Resident Doctor
Sheikh Zayed Federal Postgraduate Medical Institute