Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences (PRE-PRURINEO)

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT06551363
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-03-01
• Primary Completion: 2018-04-26
• Study Completion: 2018-04-26
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Focal sampling and Scan sampling of the behaviors	6 month	Frequency of behaviors observed by the method of "focal sampling" and "scan sampling".; All behavioral responses of the infants will be quantified from the video recordings.

Secondary Outcome Measures

Name	Time	Method
Frequency of behaviors according to the severity of atopic dermatitis	6 month	Frequency of focal sampling behaviors according to the severity of atopic dermatitis evaluated using SCORAD score All behavioral responses of the infants will be quantified from the video recordings.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France