Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551363
Status:
COMPLETED
Last Update Posted:
None
First Post:
2019-06-21
Brief Title:
Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year Analysis of Filmed Sequences PRE-PRURINEO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year Analysis of Filmed Sequences
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-PRURINEO
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None