Children's Respiratory and Environmental Workgroup

NCT03213184 — Completed, 142 participants, University of Wisconsin, Madison

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Children's Respiratory and Environmental Workgroup (CREW)02

Registry	NCT03213184, acronym CREW02
Status	Completed
Study type	Observational
Enrollment	142 (Actual)
Sponsor	University of Wisconsin, Madison (Other); collaborators: National Institutes of Health (NIH), University of Chicago, University of California, San Francisco, Harvard School of Public Health (HSPH), University of Arizona
Conditions	Asthma, Allergic Asthma, Allergies, Healthy
Dates	start 2017-12-26, primary completion 2023-06-30, completion 2023-06-30, first posted 2017-07-11, last updated 2023-08-14
Locations	10 sites in United States

-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.

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+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.

+Outcome measures

Primary outcomes

Forced Expiratory Volume in the first second (FEV1) [7 years]: Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.

Secondary outcomes

Asthma Control Test (ACT) [7 years]: Asthma symptoms of children leading to differing asthma severity (none, mild, moderate, severe) will be measured using the ACT questionnaire at all ages.
Immunoglobulin E (IgE) [7 years]: Total IgE will be measured serologically and will be used to determine level of allergy in all ages over 7 years.

+Eligibility

Sex: All, accepts healthy volunteers

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.

+Locations (10)

Facility	City	Country
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

+Investigators

James Gern, MD, Principal investigator, UW Madison
Daniel Jackson, MD, Principal investigator, UW Madison

+Funding

NIH grants: 1UG3OD023282, 5UH3OD023282-05

My Notes

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