The Alberta BLOOM Premature Child Study

NCT05011071 | Enrolling By Invitation

• 1 other identifier: REB20-1442
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational clinical cohort study involving 405 children born premature (at less than 37 weeks gestation) and their mother/parent/guardian. The purpose of the study is to investigate how the microbiome (the collection of microbes in a biological site) of children develops over the first years of life and its associations with the risk of childhood health outcomes including allergies and asthma. The study will also examine how perinatal factors associate with patterns of microbiome development, and their effects on the microbiome, metabolome (the collection of metabolites in a biological sample) and immune development of this population in the first years of life.

Conditions

Infant Conditions; Infant, Premature, Diseases; Asthma; Asthma in Children; Infant ALL; Allergy

Keywords

Microbiota; Microbiome; Gastrointestinal Microbiome; immunobiome

Outcome Measures

Primary Outcomes (1)

• Infant outcomes at 1 and 3 years of age

  Infant outcomes as assessed by the Asthma Predictive Index, a validated methodology that helps predict asthma in young children by determining history of wheeze, atopic dermatitis, familial history and eosinophilia, and skin reactivity to common allergens via a skin prick test.

  1-3.5 Years Corrected Gestational Age

Secondary Outcomes (3)

• Microbiome

  0-3.5 Years Corrected Gestational Age

• Metabolome

  0-3.5 Years Corrected Gestational Age

• Perinatal factors and microbiome, metabolome and immunobiome

  0-3.5 Years Corrected Gestational Age

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study recruits children born premature that reside in the Calgary Metropolitan Area and their mother (where possible) parent or guardian. Children are recruited either in the first week of life or, if previously participated on at least one of the PROBIO, BLOOM PTN, Pregnancy During the Pandemic or BLOOM LTFU studies, between 3 months and 3.5 years corrected age. A control group of children born at term (≥37 weeks gestation) will also be recruited.

You may qualify if:

• Less than 8 days of age or previous participation in one of the BLOOM-PTN, BLOOM-LTFU, Pregnancy During the Pandemic or PROBIO studies;
• Born at ≤ 36 weeks + 6 days gestation (36 6/7 weeks gestational age)
• For babies recruited shortly after birth, be expected to survive more than one week;
• Provide a signed and dated consent form;
• Be able to speak and understand English;
• Be 16 years of age or older;
• Be willing to comply with all study procedures and be available for the duration of the study;
• If recruited as a previous participant of the BLOOM-PTN, BLOOM-LTFU, Pregnancy During the Pandemic and/or PROBIO studies, must be willing to attend clinic visit(s) at the Alberta Children's Hospital in Calgary, Alberta at 1 and 3 years Corrected Gestational Age, or
• If recruited within 8 days of birth, must reside within the Calgary Metropolitan Region.

You may not qualify if:

• Has major congenital or chromosomal anomalies, including any congenital gastrointestinal anomalies
• Children recruited within 8 days of birth who have a history of gastrointestinal surgery at the time of recruitment
• Not the legal guardian of the child or
• In a legal guardianship dispute.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Children's Hospital Research Institute: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Links

• Alberta BLOOM Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Infant Samples: fecal, urine, hair, blood, nasopharyngeal swab. Maternal Samples: fecal and expressed breast milk.

MeSH Terms

Conditions

Infant, Premature, Diseases; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Marie-Claire Arrieta, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: October 21, 2021
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)