Effect of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. A Randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- •To assess the effect of multisensory stimulation on behavioural status among preterm infants.
研究概览
简要总结
This study is the randomized control trial to know the effect of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. Clinical characteristics of neonate will be collected from the case sheet. According to the sequence order the subject will be allocate to the experimental and control group. The Experimental group will receive multisensory stimulation for 10 days. In both the groups physical growth will be assessed on day 10 & the corrected gestational age of 40 weeks then once a month till 6 months.
Physiological parameters will be assessed daily till discharge.Behavioural status will also be assessed daily till discharge.Motor and mental development will be assessed at 3rd month &6th month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: 1.Neonates delivered between 34-37 weeks of gestation 2.Neonates who are hemodynamically stable.
排除标准
- •Exclusion Criteria: Neonates with any of the following criteria, 1.Neonates with weight <1000gm.
- •2.Neonates with weight >2500gm.
- •3.Neonates with major congenital anomalies.
- •4.Neonates who have undergone surgery.
- •5.Neonates who are critically ill.
- •6.Neonates who are on oxygen therapy.
- •7.Neonates with hypoxic encephalopathy.
- •8.Neonates with hypoglycemic seizures 9.significant birth trauma.
结局指标
主要结局
•To assess the effect of multisensory stimulation on behavioural status among preterm infants.
时间窗: Day 1,Day10, Week 40.
•To assess the effect of multisensory stimulation on physical growth (Weight, Length, Head circumference) among preterm infants.
时间窗: Day 1,Day10, Week 40.
•To assess the effect of multisensory stimulation on physiological parameters (Heart rate, Respiratory rate, SpO2, Temperature).
时间窗: Day 1,Day10, Week 40.
次要结局
- •To assess the effect of multisensory stimulation on motor & mental development among preterm infants at 3 month & 6 month.(•To identify the clinical characteristics associated with developmental, behavioural, physical & physiological outcome among the preterm neonates.)