NCT04325451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 3, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

March 24, 2020

Last Update Submit

November 2, 2022

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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.

    6 months

  • 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.

    24 months

  • To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD

    6 months

  • To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD

    12 months

  • To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD

    24 months

  • +6 more secondary outcomes

Eligibility Criteria

Age24 Hours - 120 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates will be recruited from maternity wards amongst the general population within the first five days of life

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meir Medical Center

Kfar Saba, Israel

Location

Poriya Medical Center

Tiberias, Israel

Location

Related Publications (1)

  • 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.

    PMID: 36282128DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Tatiana Smolkin, MD

    Poriah Medical Center

    PRINCIPAL INVESTIGATOR

  • Tzofia Bauer, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

June 3, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)