NCT05011071Enrolling by invitation
The Alberta BLOOM Premature Child Study
The Alberta BLOOM Premature Child Study: Impact of the Microbiome on the Clinical Course and Health Outcomes of Premature Children
Source: ClinicalTrials.gov · Last updated 24 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 535 (estimated)
- First submitted
- 11 Aug 2021
- Start date
- 21 Oct 2021
- Primary completion date
- Aug 2027
- Lead sponsor
- University of Calgary
- Diseases
- Asthma
- NCT number
- NCT05011071
What you commit to
- Study type: Observational
- Planned participants: 535
- From 21 Oct 2021 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 0 days to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.