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临床试验/NCT02048202
NCT02048202Unknown不适用

Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff

The Baruch Padeh Medical Center, Poriya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
◦Developmental assessment - a composite of several measures

研究概览

简要总结

The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

详细描述

Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

年龄范围
— 至 4 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • neonates wherein their parents have expressed consent to participate in trail
  • neonates with parents who are able to understand and fill in questioners
  • neonates with no chromosomal deficiencies and no genetic deficiency

排除标准

  • neonates with parents who are unable to understand and fill in questioners
  • neonates with intraventricular bleeding IVH/PVH
  • neonates with periventricular hemorrhage
  • neonates with known chromosomal deficiencies or genetic deficiency

结局指标

主要结局

◦Developmental assessment - a composite of several measures

时间窗: ◦Time Frame: 3 month

次要结局

  • Developmental assessment - a composite of several measures(◦◦Time Frame: 18 month)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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