The Alberta BLOOM Premature Child Study
Key facts
- Where
- Calgary, CanadaSee the site
Where in Canada
- University Of CalgaryCalgary, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Calgary
- Trial code
- NCT05011071
- Record updated
- 24 December 2024
- Original description
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.Read full original descriptionShow less
The Alberta BLOOM Premature Child Study: Impact of the Microbiome on the Clinical Course and Health Outcomes of Premature Children
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.
Inclusion: Child Inclusion Criteria:; 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; Mother/Parent/Legal Guardian Inclusion Criteria:; 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.
Exclusion: 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:; Child Exclusion Criteria:; Has major congenital or chromosomal anomalies, including any congenital gastrointestinal anomalies; Not the legal guardian of the child or; In a legal guardianship dispute.