Effect of capacity building and empowering the accompanying parent attendants, for delivery of ‘package of care’ to their sick neonate admitted to a tertiary level referral nicu – special reference to nosocomial infection rate: a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,157
- 试验地点
- 1
- 主要终点
- Culture positive nosocomial infection rate defined as number of episodes of culture proven nosocomial infections per thousand baby days of admission.
研究概览
简要总结
This was a randomised controlled trial to study the impact of parent-attendant involvement in providing a package of care to their sick neonate, on nosocomial infection in a tertiary level neonatal intensive care unit with an overarching aim to adapt the principles of family centred care to decrease the nosocomial infection in a tertiary level referral nursery.We hypothesised that translating and adapting principles of family centred care to an operational and culturally sensitive module which empowers families to take care of their sick baby in nursery, results in decreasing nosocomial infection rate in a tertiary level referral nursery by 50%.
295 babies were randomized into 148 in intervention and 147 in control group. Babies in study group received intervention in form of a supervised delivery of a package of care to their sick newborn by his / her parent attendants through an indigenously prepared audio visual module. This intervention in the study group was in addition to the standard care provided by the nurses/doctors in nursery as in the control group. Primary outcome variable was difference in culture positive nosocomial infection rate in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •all neonates admitted to tertiary level nursery of RMLH accompanied by atleast 2 parent attendants who were willing to participate in study.
排除标准
- •refusal to consent, haemodynamically unstable babies, with gross major malformation, twins or triplets where more than 2 parent attendants with individual baby were not available.
结局指标
主要结局
Culture positive nosocomial infection rate defined as number of episodes of culture proven nosocomial infections per thousand baby days of admission.
时间窗: january 2011 - marcn 2012
次要结局
- mortality(january 2011 - marcn 2012)
- Median duration of hospital stay.(january 2011 - marcn 2012)
- Culture negative nosocomial infection rate defined as number of episodes of culture negative nosocomial infections per thousand baby days of admission.(january 2011 - marcn 2012)