Clinical trial NCT03684343: Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Official title: Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 48
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Atopic dermatitis patients :

Inclusion Criteria:

* 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

Primary outcomes:
measure: Frequency of occurrence of each behaviors
timeFrame: Day 0
measure: Percentage of time passed to express each behavior
timeFrame: Day 0
Secondary outcomes:
measure: SCORin Atopic Dermatitis
timeFrame: Day 0
measure: Tactile sensitivity test
timeFrame: Day 0
measure: Laterality test
timeFrame: Day 0
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: