Clinical trial NCT06551363: Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences (PRE-PRURINEO)
Official title: Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
infant
Etology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 7
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with moderate to severe atopic dermatitis less than 1 year old

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Focal sampling and Scan sampling of the behaviors
timeFrame: 6 month
Secondary outcomes:
measure: Frequency of behaviors according to the severity of atopic dermatitis
timeFrame: 6 month
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: