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临床试验/NCT04247308
NCT04247308已完成不适用

Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants

Asir John Samuel2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Infant Neurological International Battery

研究概览

简要总结

A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time.

Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
2 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born between 28 and 36 week of gestation
  • Birth weight ranging from 1000-2500 g.
  • Medically stable preterm infants

排除标准

  • Medically unstable preterm infants.
  • Infants with congenital anomalies, congenital infections and central nervous system injury

结局指标

主要结局

Infant Neurological International Battery

时间窗: Change from baseline and 2 weeks

Infant Neurological International Battery (INFANIB), the minimum and maximum values are 14 and 70 respectively, and higher scores mean a better outcome. Scores less than and equal to 48 is abnormal while greater than and equal to 66 means normal.

次要结局

未报告次要终点

研究者

发起方
Asir John Samuel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Asir John Samuel

Associate Professor

Maharishi Markendeswar University (Deemed to be University)

研究点 (2)

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