AzTrials
AzTrials

Asthma in ChildrenCANOENCT04215783

Childhood Allergy and the Neonatal Environment

An observational study of Asthma in Children and Allergy, run by University of Wisconsin, Madison at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this research study is to study the relationship between childhood asthma, allergies, and early-life environmental factors that may cause childhood asthma and allergies. Read more about this study

Who is it for?
Any age
Conditions the study is for
Asthma in Children, Allergy
How many people
499 participants
Where
4 sitesUnited States
Study dates
4 Mar 2020to 31 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study participants of CANOE will consist of four ethnically diverse cohorts from predominantly urban and suburban families at 4 sites. Previous studies have identified common themes in populations of children who differ by ethnicity and environmental exposures. These include inverse relationships between wheezing and/or atopy and exposure to specific microbes and allergens in early life. Obtaining prospective data from newly recruited participants during the prenatal period offers multiple opportunities to optimize sample collection for assessment of environmental exposures and enhance the scientific value of the CREW consortium. To enrich the cohort for the development of wheezing and allergic sensitization, we will enroll participants with a family history of asthma or allergies.

Who may be able to join

  • History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic parent or sibling (at least one shared biological parent) by parental report. The presence of paternal or sibling allergy or asthma will be ascertained by maternal report.
  • Maternal age greater than or equal to 18 years at the time of study enrollment.

Who cannot join

  • Maternal HIV infection at time of delivery.
  • Plans for the family to move out of the geographic area during the period of the study.
  • Does not speak English.
  • Current maternal use of progesterone during pregnancy to prevent preterm birth.
  • Progesterone use is only an exclusion if currently being taken at time of enrollment for preterm birth. Previous use to prevent preterm birth or use at any time for other indications is allowed.
  • Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are permitted).
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Henry Ford Health Systems

    Detroit, Michigan, 48202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

The purpose of this research study is to study the relationship between childhood asthma, allergies, and early-life environmental factors that may cause childhood asthma and allergies. Previous birth cohort studies have found early-life environmental factors such as allergies, pollutants, viruses and bacteria have all contributed to the development of asthma and allergies. Investigators are doing this research because there continues to be a strong need to understand the root causes of asthma and allergies. The CANOE study is an observational cohort study, which means investigators are not asking participants or participant's child to change their medications and investigators will not be giving participants or participant's child a study drug.

Read the detailed description

The CANOE study will provide an opportunity to collect novel longitudinal samples not available from the current CANOE birth cohorts, as well as enhanced and standardized environmental sampling in early life. One of the main goals of this study is to gather data and specimens, beginning in the prenatal periods, that will assess environmental exposures to toxins and microbes, and host characteristics including genetics, epigenetics, gene expression, the proteome and metabolome, microbial colonization and viral respiratory infections. The main study outcomes will be important interim conditions (e.g., recurrent wheeze, early multiple sensitization) that are highly associated with the development of asthma. Additional outcomes (perinatal outcomes, growth, neurocognitive development) will be collected as part of the collaborative Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol.

Keywords
Allergy, Asthma, Children, Birth cohort
Medical subject headings
Hypersensitivity, Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of children with recurrent wheeze

    Number of children with recurrent wheezing will be reported. Recurrent wheeze, defined as at least 2 episodes of wheeze with one occurring in the last 12 months of study participation for children between 2 and 3 years of age.

    Measured: 3 years

  2. Number of children with early aeroallergen sensitization

    Number of children with early aeroallergen sensitization will be reported. Early aeroallergen sensitization, defined as sensitization to at least one aeroallergens by age 2 years.

    Measured: 2 years

  3. Number of children diagnosed with asthma

    Number of children who diagnosed, either by a doctor or self-report, at age 6 or 7 years.

    Measured: 4 years

Secondary outcomes (3)

  1. Number of children with Atopic dermatitis (AD)

    Number of children with AD will be reported. Atopic dermatitis, defined if at least 1 of the following is present:

    1. Physician diagnosis of eczema/AD (either study physician or other physician by parental report) at any time,
    2. Objective SCORAD (SCORing Atopic Dermatitis) ≥ 8 at 1 or more study assessments. The range of the objective SCORAD lies between 0 and 83. Based on the objective SCORAD, the severity of AD can be classified into mild (<15), moderate (between 15 and 40) and severe (greater than or equal to 40) AD.
    3. Parent report of an itchy rash outside of the diaper area lasting for at least 7 days and not diagnosed as another condition.

    Measured: 3 years

  2. Number of children with food allergies

    Number of children with the food allergy will be reported. Food allergy defined as typical signs and symptoms of immediate IgE (Immunoglobulin E) -mediated reaction (such as urticaria, angioedema, vomiting, wheezing, cough, hypotension) within 2 hours of food ingestion and with positive immunocap testing to that food.

    Measured: 3 years

  3. Lung function

    Lung function is assessed by spirometry, a 10-15 minute, non-invasive, and painless test that requires participants to breathe through a mouthpiece connected to a computer, often with a nose clip to prevent air leaks. Spirometry measures lung function by calculating the volume and speed of air exhaled, and is reported as a ratio of the two.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start4 Mar 2020
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04215783
Sponsor's protocol ID
2019-1103
Other IDs
5UH3OD023282, 1U24AI152177-01, MSN236000, A536770, SMPH/PEDIATRICS/AIR, Protocol Version 1/23/2026, 1R01AI202514-01
Acronym
CANOE
Status last verified
Feb 2026
First submitted
30 Dec 2019
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma in Children and Allergy, run by University of Wisconsin, Madison at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of children with recurrent wheeze (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04215783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in