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Clinical Trials in Canada / NCT05011071
Enrolling by invitation Observational

The Alberta BLOOM Premature Child Study

NCT05011071 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2021-10-21
Last updated
2024-12-24

Condition(s) studied

Infant ConditionsInfant, Premature, DiseasesAsthmaAsthma in ChildrenInfant ALLAllergy

Study 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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
—
Healthy volunteers
No
Inclusion Criteria Child Inclusion Criteria: 1. Less than 8 days of age or previous participation in one of the BLOOM-PTN, BLOOM-LTFU, Pregnancy During the Pandemic or PROBIO studies; 2. Born at ≤ 36 weeks + 6 days gestation (36 6/7 weeks gestational age) 3. For babies recruited shortly after birth, be expected to survive more than one week; Mother/Parent/Legal Guardian Inclusion Criteria: 1. Provide a signed and dated consent form; 2. Be able to speak and understand English; 3. Be 16 years of age or older; 4. Be willing to comply with all study procedures and be available for the duration of the study; 5. 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 6. If recruited within 8 days of birth, must reside within the Calgary Metropolitan Region. Exclusion Criteria Child Exclusion Criteria: 1. Has major congenital or chromosomal anomalies, including any congenital gastrointestinal anomalies 2. Children recruited within 8 days of birth who have a history of gastrointestinal surgery at the time of recruitment Mother/Parent/Legal Guardian Exclusion Criteria: 1. Not the legal guardian of the child or 2. In a legal guardianship dispute.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Calgary Calgary Alberta

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05011071 on ClinicalTrials.gov ↗ ← All trials in Canada