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临床试验/NCT05137873
NCT05137873
已完成
不适用

Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 60 人2022年4月14日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Great Vessels Transposition Surgery
发起方
Assistance Publique - Hôpitaux de Paris
入组人数
60
试验地点
1
主要终点
The Dunn-2 infant Sensory Profile Score one week after surgery
状态
已完成
最后更新
上个月

概览

简要总结

The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

详细描述

Baby's development takes its roots in sensorimotricity. Baby coordinates different senses (visual, auditory, tactile, taste, vestibular) to understand the space around him and to implement voluntary motor strategies. These sensory links also allow him to invest hisoral zone and consolidate his oral feeding. Another good sensory integration is necessary for a child to develop harmoniously on motor and psychic levels. In 2018 the study of L. Dagenais revealed a gap in posturomotor development on babies operated on for isolated congenital heart disease. However nobody assess sensory disorders in these babies. With this study the investigators wish to clarify the sensory impact in this situation.

注册库
clinicaltrials.gov
开始日期
2022年4月14日
结束日期
2024年8月5日
最后更新
上个月
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • Infant born at term (over 37 weeks)
  • With heart disease, of the transposition of the great vessels type, whether or not associated with an interventricular communication
  • Having a cranial perimeter in the norm at birth: between 32 and 37 cm.
  • Surgery scheduled before the age of 6 months
  • No opposition from parents

排除标准

  • Other disease or malformation
  • Parents who do not speak French

结局指标

主要结局

The Dunn-2 infant Sensory Profile Score one week after surgery

时间窗: 1 week after surgery

The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process. PS2-N has 25 variables rated from 0 to 5. The sum of these variables is the total raw score: 0 to 30: much less than others 31 to 40: less than the others 41 to 61 : Like the majority 62 to 71: more than the others 72 to 125 : much less than the others

次要结局

  • The Dunn-2 infant Sensory Profile Score one month after surgery(1 month after surgery)
  • Eating disorders 6 months after surgery(6 months after surgery)
  • Eating disorders one month after surgery(1 month after surgery)
  • The Dunn-2 infant Sensory Profile Score 6 months after surgery(6 months after surgery)
  • Implementation of functional rehabilitation 1 month after surgery(1 month after surgery)
  • Implementation of functional rehabilitation 6 months after surgery(6 months after surgery)
  • Eating disorders one week after surgery(1 week after surgery)

研究点 (1)

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