Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798079
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2021-03-05
Brief Title:
Systems Biology of Early Atopy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Systems Biology of Early Atopy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUNBEAM
Brief Summary:
The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis AD to identify prenatal and early life markers of high risk for food allergy and AD as well as biological pathways endotypes that result in these conditions
Primary Objectives
To study the role and interrelationships of established and novel clinical environmental biological and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years with an emphasis on atopic dermatitis and food allergy
To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy atopic dermatitis and their endotypes
To collect process and assay or store environmental and biological samples for current and future use in the study of allergic disease development
Primary Objectives
To study the role and interrelationships of established and novel clinical environmental biological and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years with an emphasis on atopic dermatitis and food allergy
To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy atopic dermatitis and their endotypes
To collect process and assay or store environmental and biological samples for current and future use in the study of allergic disease development
Detailed Description:
This is a prospective cohort study in which pregnant women at any stage of pregnancy the offsprings biologic father and the offspring will be enrolled at study sites and the offspring will be observed from birth to age 3 years The enrollment goal is at least 2500 pregnant women who agree to enroll their offspring at birth Enrollment of biological fathers will be attempted however enrollment of the mother or child is not dependent on enrollment of the biological father
During the study biological and environmental samples and questionnaire information will be collected from the parents and the children and the children will be assessed for allergic diseases at clinic visits at ages 2 5 12 24 and 36 months
During the study biological and environmental samples and questionnaire information will be collected from the parents and the children and the children will be assessed for allergic diseases at clinic visits at ages 2 5 12 24 and 36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM2AI130836 | NIH | 38710 | httpsreporternihgovquickSearchUM2AI130836 |
| NIAID CRMS ID | OTHER | None | None |