Comprehending Atopic Risk Elements

Atopic Dermatitis Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04325451
• Other study ID #: 0244-19-MMC
• Status: Active, not recruiting
• Start date: June 3, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2022
• Source: MYOR Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 120 Hours

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Poriya Medical Center	Tiberias

Sponsors (3)

Lead Sponsor	Collaborator
MYOR Ltd.	Meir Medical Center, The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis	Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0	24 months
Secondary	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.	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.	6 months
Secondary	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.	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.	24 months
Secondary	To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD	Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.	6 months
Secondary	To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD	Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.	12 months
Secondary	To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD	Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.	24 months
Secondary	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	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.	24 months
Secondary	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	Evaluated using the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire	12 months
Secondary	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	Evaluated using the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire	24 months
Secondary	To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis	Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0	12 months
Secondary	To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies	Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0	24 months
Secondary	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	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema. .	12 months