Children's Respiratory and Environmental Workgroup

Healthy Clinical Trial

— CREW02  

Official title:

Children's Respiratory and Environmental Workgroup (CREW)02

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213184
• Other study ID #: 2017-0837
• Secondary ID: 1UG3OD023282A536
• Status: Completed
• Start date: December 26, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma
• Allergies
• Asthma
• Healthy

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	UW Madison	Madison	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (6)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Harvard School of Public Health (HSPH), National Institutes of Health (NIH), University of Arizona, University of California, San Francisco, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in the first second (FEV1)	Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.	7 years
Secondary	Asthma Control Test (ACT)	Asthma symptoms of children leading to differing asthma severity (none, mild, moderate, severe) will be measured using the ACT questionnaire at all ages.	7 years
Secondary	Immunoglobulin E (IgE)	Total IgE will be measured serologically and will be used to determine level of allergy in all ages over 7 years.	7 years