Effectiveness of multisensory intervention with maternal participatory guidance on the health status of preterm neonates at a selected hospital, Mangaluru
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- preterm neonates,
研究概览
简要总结
The proposed study is a Randomised control trial on effectiveness of multisensory intervention with maternal participatory guidance on the health status of preterm neonates at a selected hospital, Mangaluru. Ethical clearance and required permissions for the study will be obtained appropriately. The preterm neonates and their mothers who fulfil the inclusion and exclusion criteria will be randomly assigned to the experimental (n=97) and control group (n=97) using simple random sampling technique. Informed consent will be obtained from the mothers. The preterm neonates in the experimental group will receive the multisensory intervention (ATVV stimulation) from the mothers which will be taught using a video, handout and guidance by the researcher along with routine NICU care. The control group will only receive routine NICU care. The experimental group will receive the multisensory intervention for 10 consecutive days and the observations will be done on the 1st, 5th and 10th days of intervention.The primary outcomes such as behavioural state, feeding progression and weight gain in preterm neonates will be assessed using the Andersons behavioural state scale, feeding progression scale for preterm neonates, weight record respectively. the gathered data will be subjected to statistical anlysis using repeated measures ANNOVA, Post-hoc analysis and Chi square test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)(—)
- 性别
- All
入选标准
- •Preterm neonates, • 28 -<32 weeks (very preterm) and 33 -<36 weeks gestation (moderate to late preterm) at birth as per modified Ballard score • who are hemodynamically stable during recruitment for study • weighing≥1000 grams Mothers, • of preterm neonates • who are willing to stay in the hospital with preterm neonate for a minimum of 10 days after being recruited in the study • who are able to speak and read Kannada/ Malayalam/ English language.
排除标准
- •Preterm neonates, • with congenital anomaly, necrotizing enterocolitis, brain injury, chronic lung disease • with prenatal drug exposure Mothers, •not willing to participate in the study •with psychological or psychiatric illness.
结局指标
主要结局
preterm neonates,
时间窗: day 1, day 5, day10
behavioral state
时间窗: day 1, day 5, day10
feeding progression
时间窗: day 1, day 5, day10
weight gain
时间窗: day 1, day 5, day10
次要结局
未报告次要终点
