跳至主要内容
临床试验/CTRI/2021/07/034879
CTRI/2021/07/034879尚未招募不适用

Effectiveness of multisensory intervention with maternal participatory guidance on the health status of preterm neonates at a selected hospital, Mangaluru

Sonya Sequeira1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2021年1月8日最近更新:

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

研究者

发起方
Sonya Sequeira
申办方类型
Other [Self sponsor]

研究点 (1)

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