Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,800
- 试验地点
- 1
- 主要终点
- Incidence of Neonatal Omphalitis
研究概览
简要总结
The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.
详细描述
The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.
This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.
The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
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
- •All healthy newborns, born in the study setting will be systematically enrolled in the trial
排除标准
- •Infants with congenital/birth defects
- •Infants with any localized infection on the peri-umbilical region at the time of birth or application of any other material such as dung, etc before enrollment on the Cord.
研究组 & 干预措施
A
In this arm we recruited 2,400 subjects who received Intervention.
干预措施: 4% Chlorhexidine (Drug)
B
In this Arm, we recruited 2,400 subjects who received intervention.
干预措施: Hand washing Soap (Other)
C
In this Arm, we recruited 2,400 subjects who received intervention.
干预措施: 4% Chlorhexidine (Drug)
结局指标
主要结局
Incidence of Neonatal Omphalitis
时间窗: By the end of the styudy
Rate of Neonatal Mortality
时间窗: By the end of the Study
次要结局
- Breastfeeding rate(By the end of the Study)
- Rate of Serious Neonatal Infections(By the end of the Study)
- Utilization of Clean Delivery Kits(By the end of the Study)
- Application Practice of Chlorhexidine(By the end of the Study)