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临床试验/NCT06551363
NCT06551363已完成不适用

Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Focal sampling and Scan sampling of the behaviors

研究概览

简要总结

Analysis of filmed sequences for the assessment of discomfort in atopic dermatitis in infants under 1year of age

详细描述

Atopic Dermatitis (AD) is a chronic inflammatory and itchy dermatitis particularly common in childhood since it affects about 20% of the pediatric population, with revelation usually around the age of 3-6 months of life. However, there are very few pediatric population data on the prevalence of pruritus and associated discomfort in infants. Although the skin and the nervous system of the infant (<6 months) are competent in the experiment of the pruritus, the acquisition of an intentional motricity allowing the targeted scratching of the affected body areas is done only from the age of 6 months, making it difficult to diagnose the intensity of the AD and assess the potential discomfort caused. Currently, the diagnosis and assessment of pruritus in children is based on a hetero-rating through scales, which are not at all applicable for infants under 6 months of age (population concerned by our study).

The visual scale Numeric Rating Scale, validated in adult population seems to be the one that most accurately assesses the severity of pruritus. In pediatric populations, the use of the Eppendorf Itch Questionnaire and the US version of the Childhood Atopic Dermatitis Impact Scale are recommended. Alternatives to the clinical and subjective rating of the severity of pruritus have been described via actigraphy: thus, a strong statistical correlation has been demonstrated between a nocturnal measurement of wrist motor activity as a reflection of the intensity of pruritus, and the analysis of videos filmed in infra-red. But, again, the technique is not suitable for young infants, because of the absence of voluntary motivated motor skills, and because of less organized sleep / wake cycles.

In order to better manage infants less than 1 year old, the analysis of their behavior in case of atopic dermatitis seems necessary to us to better identify a potential discomfort in these patients.

This is an essential preliminary study that will allow us to better define the judgment criteria necessary for the implementation of an observational study comparing infants with atopic dermatitis to healthy infants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Months 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Infants under 1 year old
  • with atopic dermatitis
  • No opposition from at least one of the patient's parents

排除标准

  • Acute intercurrent pathology
  • Severe malformation or genetic abnomalies
  • Parent (s) minor (s) or unfit (s) to give their informed consent
  • Refusal of patients

结局指标

主要结局

Focal sampling and Scan sampling of the behaviors

时间窗: 6 month

Frequency of behaviors observed by the method of "focal sampling" and "scan sampling". All behavioral responses of the infants will be quantified from the video recordings.

次要结局

  • Frequency of behaviors according to the severity of atopic dermatitis(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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