Comprehending Atopic Risk Elements

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04325451

Acronym

CARE

Enrollment

252

Registered

2020-03-27

Start date

2020-06-03

Completion date

2024-05-01

Last updated

2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Hours to 120 Hours

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	6 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 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 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. .
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	12 months	Evaluated using the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire

Countries

Israel

Outcome results