Comprehending Atopic Risk Elements

Active, not recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT04325451
• Lead Sponsor: MYOR Ltd.

Brief Summary

Skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (AD). Additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. However, a comprehensive study focusing on the entire spectrum of risk factors has yet to be undertaken. Such a study could enable predictive capabilities able to inform medical professionals as to a newborn's inherent risk to develop AD, and potentially recommend appropriate preventative modalities to prevent or delay disease onset.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Study Start: 2020-06-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment & less than 120 hours prior to enrollment
2. Term and near term newborns born between 34+0 and 42+0 weeks gestational age
3. Mothers must be aged >18 years
4. Parents' ability to complete questionnaire(s) at defined times throughout study duration
5. Parents or legal guardian provide informed written consent

Exclusion Criteria

1. Preterm birth prior to 34+0 weeks gestation
2. Less than 12 hours out of the incubator
3. Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
4. Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
5. Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
6. Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
7. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis	24 months	Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0

Secondary Outcome Measures

Name	Time	Method
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at six months of age.	6 months	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at two years of age.	24 months	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD	24 months	Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.
3. To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the age of onset of AD	24 months	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing food allergies	24 months	Evaluated using the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis	12 months	Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies	24 months	Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of development AD at one year of age	12 months	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema. .

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Poriya Medical Center; 🇮🇱 Tiberias, Israel