Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03684343
Status:
TERMINATED
Last Update Posted:
2023-01-23
First Post:
2018-09-11
Brief Title:
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inclusion difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRURINEO
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 sleepwake 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None