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Infant ConditionsBLOOM-PCSNCT05011071

The Alberta BLOOM Premature Child Study

An observational study of Infant Conditions and Infant, Premature, Diseases, run by University of Calgary at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 0 days and older
How many people
535 participants
Where
1 siteCanada
Study dates
21 Oct 2021to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 2T9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Keywords
Microbiota, Microbiome, Gastrointestinal Microbiome, immunobiome
Medical subject headings
Infant, Premature, Diseases, Asthma, Hypersensitivity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-3.5 Years Corrected Gestational Age

Secondary outcomes (3)

  1. Microbiome

    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.

    Measured: 0-3.5 Years Corrected Gestational Age

  2. Metabolome

    Human and microbial metabolites as assessed by untargeted metabolomics, ultra-performance liquid chromatography ultrahigh-resolution Fournier transform (FT) combined with mass spectrometry.

    Measured: 0-3.5 Years Corrected Gestational Age

  3. Perinatal factors and microbiome, metabolome and immunobiome

    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.

    Measured: 0-3.5 Years Corrected Gestational Age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start21 Oct 2021
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
535 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011071
Sponsor's protocol ID
REB20-1442
Acronym
BLOOM-PCS
Status last verified
Dec 2024
First submitted
11 Aug 2021
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Asbury MR, Guedez A, Lee J, Mercer EM, Kasaba F, Rangipour Z, Kellner JD, Lacaze-Masmonteil T, Samara J, Leijser LM, Lebel C, Zein H, Hendson L, Murguia Favela L, McNagny K, Giesbrecht GF, Sycuro L, Alshaikh B, Arrieta MC. Exploring the Early-Life Microbiomes of Preterm Infants and Their Childhood Health Outcomes (The BLOOM Study): Protocol for a Prospective, Observational Cohort Study. JMIR Res Protoc. 2026 Aug 18;15:e95658. doi: 10.2196/95658.

    PubMed 42612036

Questions about this trial

What is this clinical trial studying?

An observational study of Infant Conditions and Infant, Premature, Diseases, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant outcomes at 1 and 3 years of age (time frame: 1-3.5 Years Corrected Gestational Age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011071, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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