Status:
UNKNOWN
Comprehending Atopic Risk Elements
Lead Sponsor:
MYOR Ltd.
Collaborating Sponsors:
Meir Medical Center
The Baruch Padeh Medical Center, Poriya
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
24-120 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04325451
Start Date
June 3 2020
End Date
May 1 2024
Last Update
November 3 2022
Active Locations (2)
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1
Meir Medical Center
Kfar Saba, Israel
2
Poriya Medical Center
Tiberias, Israel