Comprehending Atopic Risk Elements (CARE)

MyOR

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04325451

0244-19-MMC

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 24 to 120 hours old

Volunteers: Accepts Healthy Volunteers

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