Project 500 CHILD Study

NCT03225534 | Unknown

• 1 other identifier: Project 500 ISS
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

This proposal relates to the testing of several specific hypotheses in a subset of 500 participants in the Canadian Healthy Infant Longitudinal Development (CHILD) Study. These 500 now have complete data from the time of recruitment (in pregnancy) to age 1 year. The primary purpose of this proposal is to identify risk factors for early allergic outcomes and biomarkers that may predict future disease. These 500 infants will provide critical preliminary data, not only related to early outcomes, but also to inform analytical plans for the full CHILD cohort.

Conditions

Asthma in Children; Allergy in Children; Environmental Exposure; Genetic Predisposition

Keywords

Asthma; Allergy; Epidemiology; Environment; Exposures

Outcome Measures

Primary Outcomes (1)

• Allergic sensitization at 1 year

  Skin prick tests to food and inhalant allergies

  March 2018

Secondary Outcomes (2)

• Early childhood wheeze

  Birth to one year

• Atopic Dermatitis

  Birth to one year

Other Outcomes (1)

• Food Allergy

  Birth to one year

Eligibility Criteria

• Age: 1 Day - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The 500 children in Project 500 will be representative of our full cohort. Study members have been recruited from a general population (i.e., not high-risk for asthma and allergy as are many cohorts) from recruitment bases in Vancouver, Edmonton, Winnipeg (including a rural site in Manitoba) and Toronto.

You may qualify if:

• Pregnant women aged 18 years and older (19 in Vancouver) 2. Residence in reasonable proximity to the delivery hospital 3. Able to read, write, and speak English 4. Willing to provide informed consent 5. Willing to consent to cord blood collection for the study 6. Planning to give birth at a designated recruitment centre participating hospital 7. Infants born at or after 35 weeks 8. Able to provide address and telephone number and names and telephone numbers of two alternate contact individuals

You may not qualify if:

• Children with major congenital abnormalities or respiratory distress syndrome (RDS)
• Expectation of moving away from a recruitment area within year 1
• Children of multiple births
• Children resulting from in vitro fertilization
• Children who will not spend at least 80% of nights in the index home

Sponsors & Collaborators

• McMaster University: lead
• Allergy, Genes and Environment Network (AllerGen) NCE: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• St. Joseph's Healthcare Hamilton: collaborator
• University of Toronto: collaborator
• University of Manitoba: collaborator
• University of Alberta: collaborator
• University of British Columbia: collaborator

Related Publications (4)

• Takaro TK, Scott JA, Allen RW, Anand SS, Becker AB, Befus AD, Brauer M, Duncan J, Lefebvre DL, Lou W, Mandhane PJ, McLean KE, Miller G, Sbihi H, Shu H, Subbarao P, Turvey SE, Wheeler AJ, Zeng L, Sears MR, Brook JR; CHILD study investigators. The Canadian Healthy Infant Longitudinal Development (CHILD) birth cohort study: assessment of environmental exposures. J Expo Sci Environ Epidemiol. 2015 Nov-Dec;25(6):580-92. doi: 10.1038/jes.2015.7. Epub 2015 Mar 25.

  PMID: 25805254 BACKGROUND

• Moraes TJ, Lefebvre DL, Chooniedass R, Becker AB, Brook JR, Denburg J, HayGlass KT, Hegele RG, Kollmann TR, Macri J, Mandhane PJ, Scott JA, Subbarao P, Takaro TK, Turvey SE, Duncan JD, Sears MR, Befus AD; CHILD Study Investigators. The Canadian healthy infant longitudinal development birth cohort study: biological samples and biobanking. Paediatr Perinat Epidemiol. 2015 Jan;29(1):84-92. doi: 10.1111/ppe.12161. Epub 2014 Nov 18.

  PMID: 25405552 BACKGROUND

• Subbarao P, Anand SS, Becker AB, Befus AD, Brauer M, Brook JR, Denburg JA, HayGlass KT, Kobor MS, Kollmann TR, Kozyrskyj AL, Lou WY, Mandhane PJ, Miller GE, Moraes TJ, Pare PD, Scott JA, Takaro TK, Turvey SE, Duncan JM, Lefebvre DL, Sears MR; CHILD Study investigators. The Canadian Healthy Infant Longitudinal Development (CHILD) Study: examining developmental origins of allergy and asthma. Thorax. 2015 Oct;70(10):998-1000. doi: 10.1136/thoraxjnl-2015-207246. Epub 2015 Jun 11.

  PMID: 26069286 BACKGROUND

• Azad MB, Robertson B, Atakora F, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Bode L. Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. J Nutr. 2018 Nov 1;148(11):1733-1742. doi: 10.1093/jn/nxy175.

  PMID: 30247646 DERIVED

Related Links

• Overview of the CHILD Study

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood. Child 1 year blood Child 5 year blood. Parental venous blood. Saliva samples. Urine samples. Stool samples. Breast milk samples. Nasal swabs.

MeSH Terms

Conditions

Genetic Predisposition to Disease; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Padmaja Subbarao, MD

  University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 21, 2017
• Study Start: August 31, 2008
• Primary Completion: October 31, 2012
• Study Completion: March 31, 2018
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share