Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.
研究概览
简要总结
Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't.
详细描述
This study will be conducted at Neonatal Intensive Care Unit (NICU) of Alexandria University Children's Hospital (AUCH) at Smouha, Alexandria, egypt.
A sample of 60 preterm neonates.The study subjects will be randomly assigned into two equal groups (control and multi-sensory stimulation groups) using random number table. Each group will be comprised of 30 neonates. The first neonate will be assigned to the control group and the second neonate will be assigned to the multi-sensory stimulation group.
Control group: Preterm neonates will receive only routine care of the unit. Multi-Sensory Stimulation group: Preterm neonates will receive multi-sensory stimulation intervention beside routine care of the unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age ranges from 32 and 36 weeks.
- •The preterm infant's 5 min Apgar is 6 and more.
排除标准
- •History of cardiopulmonary resuscitation or surgery.
- •History of intraventricular hemorrhage grade II and above.
- •Major congenital malformations
结局指标
主要结局
Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.
时间窗: It will be assessed "baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change.
It was monitored using Neonatal Neurobehavioral Examination Scale (NNE). it is reliable and valid scale for assessing neurobehavioral development of neonates.It includes three main categories: tone and motor patterns, primitive reflexes, and behavioral responses. the total items of scale were 27, with total score ranged between 27 to 81, which high score means a better outcome and low score means a worse outcome.
次要结局
- Birth weight of preterm neonate(It will assessed initially before conducting the study.)
- Gestational age(It will assessed initially before conducting the study.)
- Residence.(It will assessed initially before conducting the study.)
- Number of para.(It will assessed initially before conducting the study.)
- Plurality.(It will assessed initially before conducting the study.)
- Apgar score at 1 and 5 minutes.(It will assessed initially before conducting the study.)
- amount of feeding.(It will assessed initially before conducting the study.)
- Length of NICU stay(It will assessed initially before conducting the study.)
- Neonate mother's age(It will assessed initially before conducting the study.)
- Type of delivery.(It will assessed initially before conducting the study.)
- Number of abortion.(It will assessed initially before conducting the study.)
- Neonate's weight(It will assessed initially before conducting the study.)
- Type of feeding.(It will assessed initially before conducting the study.)
- Number of gravida.(It will assessed initially before conducting the study.)