An Observational Study to Determine Lifestyle, Biophysical and Environmental Risk Factors in the Development of Early-onset Pediatric Atopic Dermatitis

MYOR Ltd.2 sites in 1 country252 target enrollmentJune 3, 2020

ConditionsAtopic Dermatitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: MYOR Ltd.
Enrollment: 252
Locations: 2
Primary Endpoint: To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2020

End Date

May 1, 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MYOR Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Preterm birth prior to 34+0 weeks gestation
•Less than 12 hours out of the incubator
•Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
•Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
•Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
•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
•Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Outcomes

Primary Outcomes

To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis

Time Frame: 24 months

Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0

Secondary Outcomes

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)
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)
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)
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)
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)
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis(12 months)
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies(24 months)
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)