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

Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences

Analysis of filmed sequences for the assessment of discomfort in atopic dermatitis in infants under 1year of age

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Infants with moderate to severe atopic dermatitis less than 1 year old

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Focal sampling and Scan sampling of the behaviors	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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of behaviors according to the severity of atopic dermatitis	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.	6 month

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): April 26, 2018
• Study Completion (Actual): April 26, 2018

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Atopic dermatitis; infant; Etology
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 29BRC18.0023 - PRE-PRURINEO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No