Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
- Conditions
- Atopic Dermatitis
- Interventions
- Other: Filmed consultation with a dermatologist
- Registration Number
- NCT03684343
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy patients Filmed consultation with a dermatologist Filmed consultation with a dermatologist. Laterality and tactile sensitivity test. Atopic Dermatitis patients Filmed consultation with a dermatologist Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
- Primary Outcome Measures
Name Time Method Frequency of occurrence of each behaviors Day 0 The frequency of occurrence of each behaviors will be identify.
Percentage of time passed to express each behavior Day 0 The percentage of time passed to express each behavior will be noted.
- Secondary Outcome Measures
Name Time Method SCORin Atopic Dermatitis Day 0 SCORAD is a severity score used for atopic dermatitis. Only patients with AD will performed this test. SCORAD\<25 : mild AD; 25\<SCORAD\<50 : moderate AD and SCORAD \>50 : severe AD
Tactile sensitivity test Day 0 Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.
Laterality test Day 0 An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.
Trial Locations
- Locations (1)
CHRU de Brest
🇫🇷Brest, France