Comprehending Atopic Risk Elements (CARE)

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    500
  • sponsor
    MYOR Ltd.
Updated on 18 April 2022
atopy
Accepts healthy volunteers

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.

Details
Condition Atopic Dermatitis
Clinical Study IdentifierNCT04325451
SponsorMYOR Ltd.
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment & less than 120 hours prior to enrollment
Mothers must be aged >18 years
Term and near term newborns born between 34+0 and 42+0 weeks gestational age
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
Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
Less than 12 hours out of the incubator
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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