Clinical trial NCT04325451: Comprehending Atopic Risk Elements
Official title: An Observational Study to Determine Lifestyle, Biophysical and Environmental Risk Factors in the Development of Early-onset Pediatric Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Lead sponsor: MYOR Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Meir Medical Center
name: The Baruch Padeh Medical Center, Poriya
First posted: 2020-03-27
Enrollment: 252
Sex: ALL
Minimum age (years): 24
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates will be recruited from maternity wards amongst the general population within the first five days of life

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.


Eligibility criteria: 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

Primary outcomes:
measure: To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
timeFrame: 24 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 24 months
measure: To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
timeFrame: 6 months
measure: To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
timeFrame: 12 months
measure: To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
timeFrame: 24 months
measure: 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
timeFrame: 24 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 24 months
measure: To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
timeFrame: 12 months
measure: To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies
timeFrame: 24 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tiberias
country: Israel
facility: Poriya Medical Center
Study officials:
affiliation: Poriah Medical Center
name: Tatiana Smolkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: Tzofia Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandwein M, Gamrasni K, Landau T, Bauer-Rusek S, Smolkin T. Nurture, not nature: Impaired skin barrier in infants born to urban households. Pediatr Allergy Immunol. 2022 Oct;33(10):e13868. doi: 10.1111/pai.13868. No abstract available.