- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05011071
The Alberta BLOOM Premature Child Study (BLOOM-PCS)
The Alberta BLOOM Premature Child Study: Impact of the Microbiome on the Clinical Course and Health Outcomes of Premature Children
Study Overview
Status
Detailed Description
Premature birth (birth before 37 weeks of pregnancy) occurs in about 1 in 10 pregnancies. When infants are born prematurely their gut is not as developed. One important factor in gut health is the large community of microbes (tiny living things such as bacteria) that live on the human body called the microbiome. Recent studies have shown that premature infants are more likely to experience changes to their gut microbiome that are associated with health issues, such as asthma and allergies. However, the specific microbiome features of children born preterm and the role of their microbiome in disease risk and childhood health is not well understood. The Alberta BLOOM Premature Child Study (PCS) investigates how the microbiome and immune health of premature children develops over the first years of life and its associations with the risk of childhood health outcomes. BLOOM-PCS will also study how the microbiome of children born premature differs from the microbiome in the term population.
The type of microbes that are present in the infant's gut in the first months of life have a major impact on the microbiome that will form during childhood. There are many environmental factors during pregnancy, birth and the first months of life that can impact an infant's microbiome development. Factors such as diet, exposure to antibiotics, surgical procedures, and mode of delivery can strongly affect early microbiome development. This study will investigate how these factors influence the types of early microbes present in preterm infants.
This study hypothesizes that specific microbial patterns, trajectories and/or metabolites will be significantly associated with single or a combination of perinatal maternal and/on infant factors. Also, that microbial alterations resulting from preterm birth contributes to the allergy and asthma outcomes in infants through immune mechanisms.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- University of Calgary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
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 Criteria
Child Exclusion Criteria:
- 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
Mother/Parent/Legal Guardian Exclusion Criteria:
- Not the legal guardian of the child or
- In a legal guardianship dispute.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant outcomes at 1 and 3 years of age
Time Frame: 1-3.5 Years Corrected Gestational Age
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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.
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1-3.5 Years Corrected Gestational Age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome
Time Frame: 0-3.5 Years Corrected Gestational Age
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Microbiome establishment, fecal microbial diversity and the relative abundance of bacterial and eukaryotic taxa, as assessed by sequencing of the 16S and ITS2 gene and functional analysis via shotgun metagenomatic sequencing.
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0-3.5 Years Corrected Gestational Age
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Metabolome
Time Frame: 0-3.5 Years Corrected Gestational Age
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Human and microbial metabolites as assessed by untargeted metabolomics, ultra-performance liquid chromatography ultrahigh-resolution Fournier transform (FT) combined with mass spectrometry.
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0-3.5 Years Corrected Gestational Age
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Perinatal factors and microbiome, metabolome and immunobiome
Time Frame: 0-3.5 Years Corrected Gestational Age
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Influence of perinatal factors (environment, nutrition, pharmacological exposure) on the microbiome, metabolome and immunobiome; association between perinatal factors, preterm delivery, and the patterns of microbiome, metabolome and immunobiome development.
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0-3.5 Years Corrected Gestational Age
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie-Claire Arrieta, PhD, University of Calgary
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Infant, Newborn, Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Infant, Premature, Diseases
- Asthma
- Premature Birth
Other Study ID Numbers
- REB20-1442
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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