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临床试验/NCT03684343
NCT03684343终止不适用

Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
48
试验地点
2
主要终点
Frequency of occurrence of each behaviors

研究概览

简要总结

Atopic dermatitis (AD) is an frequent chronic and itchy inflammatory dermatitis which concern about 20% of pediatric population with a revelation usually toward 3-6 months of live. However, there are very few data about the prevalence of pruritus of young infants and about the discomfort linked with it. While the skin and the nervous system of young infants (Under 6 month) are competent in pruritus experiment, the acquisition of conscious and deliberate motor ability allowing specific scratching of the body parts which are affected is possible only from 6 month. Thus, the diagnosis of AD intensity and the assesment of the potential associated discomfort are hard. At the present time, the diagnosis and the assesment of pruritus of children are based on a hetero-assesment via scales which are not applicable for infants under 6 month. The visual scale "Numeric Rating Scale" validated in adult population seems to be the most specific to assess AD severity. In pediatric population, the use of "Eppendorf Itch Questionnaire" and the american version of "Childhood Atopic Dermatitis Impact Scale" are recommended. Alternatives to clinic and subjective scoring of pruritus severity are described via actigraphy. Thus, a strong statistic correlation have been demonstrated between a nocturne measure of motor activity of wrist, as a reflect of the intensity of pruritus, and infra-red video analysis. But, once again, the technic is not adapted to young infants because of the absence of conscious and oriented motor ability and as a result of less organised sleep/wake cycle.

In order to improve young infants' (Under 6 month) care, the analysis of their behaviours with AD seems to be necessary to better identify a discomfort of these patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Young infant Under 6 month
  • Patient with AD (SCORAD between 25 and 50 for moderate AD and > 50 for severe AD)
  • Informed consent of the patient's parents
  • Healthy patients :
  • Inclusion Criteria:
  • Young infant under 6 month
  • Free of any pathology
  • Informed consent of the patient's parents
  • Exclusion Criteria (for every patients) :
  • Acute intercurrent disease
  • Severe malformation
  • Underage parents or parent unable to give their consent

排除标准

  • 未提供

结局指标

主要结局

Frequency of occurrence of each behaviors

时间窗: Day 0

The frequency of occurrence of each behaviors will be identify.

Percentage of time passed to express each behavior

时间窗: Day 0

The percentage of time passed to express each behavior will be noted.

次要结局

  • SCORin Atopic Dermatitis(Day 0)
  • Tactile sensitivity test(Day 0)
  • Laterality test(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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