Children's Respiratory and Environmental Workgroup

NCT ID: NCT03213184

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-26
• Study Completion Date: 2023-06-30

Brief Summary

The environment during the prenatal period and in early life is a major contributor to the risk of developing childhood asthma. Birth cohort studies from single research centers have identified several factors that affect the risk for developing childhood asthma, including being exposed in early life to allergens, pollutants, viruses and bacteria, and psychosocial stress. Despite such advances, further progress in understanding the root causes of asthma have been hampered by the small size of previous studies, which makes it difficult to: 1) identify asthma risk factors with certainty, 2) know how environmental factors across the United States (U.S.) affect asthma, and 3) whether there are critical ages when pregnant mothers, infants and young children are particularly susceptible to these influences. Furthermore, different research groups tend to use different methods to study asthma, making it difficult to either compare or pool findings. One other challenge is that there are several types (i.e. phenotypes, endotypes) of childhood asthma, but these are poorly understood. To help overcome these challenges, investigators leading 12 asthma birth cohorts across the U.S. have established the Children's Respiratory Research Workgroup (CREW) consortium. CREW proposes to identify specific types of childhood asthma, develop an understanding of what early life environmental influences cause these different types of asthma and when, and identify targets for future efforts aimed at preventing childhood asthma.

Detailed Description

CREW is an NIH-funded project consisting of 12 individual U.S. birth cohorts and two scientific centers working together to identify phenotypes and causes of childhood asthma. CREW will include data from a large number of children (over 9,000 at birth, 6,000-7,000 who are still being followed, and at least 5,667 expected to enroll in CREW) and their families, with broad diversity in terms of ethnicity, family characteristics, neighborhoods and geographic locations. One of the primary goals of CREW is to put together sets of data and samples of participating cohorts to identify phenotypes of childhood asthma (i.e. specific subtypes of asthma that can be distinguished by clinical features such as natural history, triggers, exacerbation frequency, concurrent allergies, lung function, sex, etc). As we obtain mechanistic insights about personal and early life risk factors, we will connect asthma phenotypes with underlying causes and pathogenic mechanisms to define endotypes of childhood asthma.

Conditions

Asthma; Allergic Asthma; Allergies; Healthy

Study Design

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

Eligibility Criteria

Inclusion Criteria

1. Participant and/or parent guardian must be able to understand and provide informed consent or assent (if required).

2. Participation in one of the 10 cohorts that make up CREW.

Exclusion Criteria

1. Inability or unwillingness of a participant to give informed consent or assent (if required) or comply with study protocol.

2. Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Gern, MD

Role: PRINCIPAL_INVESTIGATOR

UW Madison

Daniel Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

UW Madison

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UW Madison

Madison, Wisconsin, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Countries

United States

Other Identifiers

1UG3OD023282

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A536700

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\PEDIATRICS\PEDIATRICS

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol V4.0, dated 11/13/18

Identifier Type: OTHER

Identifier Source: secondary_id

5UH3OD023282-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0837

Identifier Type: -

Identifier Source: org_study_id