Comprehending Atopic Risk Elements

NCT ID: NCT04325451

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 252 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2024-05-01

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.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 120 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role: collaborator

MYOR Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatiana Smolkin, MD

Role: PRINCIPAL_INVESTIGATOR

Poriah Medical Center

Tzofia Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Poriya Medical Center

Tiberias, , Israel

Countries

Israel

References

Brandwein M, Gamrasni K, Landau T, Bauer-Rusek S, Smolkin T. Nurture, not nature: Impaired skin barrier in infants born to urban households. Pediatr Allergy Immunol. 2022 Oct;33(10):e13868. doi: 10.1111/pai.13868. No abstract available.

Reference Type: DERIVED

PMID: 36282128 (View on PubMed)

Other Identifiers

0244-19-MMC

Identifier Type: -

Identifier Source: org_study_id