Children's Respiratory and Environmental Workgroup

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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Key information

Conditions

Asthma Allergic Asthma Allergies Bronchial Diseases Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant and/or parent guardian must be able to understand and provide informed consent or assent (if required).
Participation in one of the 10 cohorts that make up CREW.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Forced Expiratory Volume in the first second (FEV1)

Time frame: 7 years

Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.

Secondary outcomes

Asthma Control Test (ACT)

Time frame: 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)

Time frame: 7 years

Total IgE will be measured serologically and will be used to determine level of allergy in all ages over 7 years.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

Harvard School of Public Health (HSPH)
National Institutes of Health (NIH)
University of Arizona
University of California, San Francisco
University of Chicago

Registry information

Official study title

Children's Respiratory and Environmental Workgroup (CREW)02

Acronym: CREW02

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Jul 11, 2017
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed