An observational study in Atopic Dermatitis, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 0 Months to 1 Year. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by University Hospital, Brest · Observational
Analysis of filmed sequences for the assessment of discomfort in atopic dermatitis in infants under 1year of age
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 7 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants with moderate to severe atopic dermatitis less than 1 year old
Exclusion Criteria:
Focal sampling and Scan sampling of the behaviors
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.
Time frame: 6 month
Frequency of behaviors according to the severity of atopic dermatitis
Frequency of focal sampling behaviors according to the severity of atopic dermatitis evaluated using SCORAD score All behavioral responses of the infants will be quantified from the video recordings.
Time frame: 6 month
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest