Clinical trial NCT05011071: The Alberta BLOOM Premature Child Study
Official title: The Alberta BLOOM Premature Child Study: Impact of the Microbiome on the Clinical Course and Health Outcomes of Premature Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infant Conditions
Infant, Premature, Diseases
Asthma
Asthma in Children
Infant ALL
Allergy
Keywords: Microbiota
Microbiome
Gastrointestinal Microbiome
immunobiome
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alberta Children's Hospital Research Institute
First posted: 2021-08-18
Enrollment: 535
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Infant outcomes at 1 and 3 years of age
timeFrame: 1-3.5 Years Corrected Gestational Age
Secondary outcomes:
measure: Microbiome
timeFrame: 0-3.5 Years Corrected Gestational Age
measure: Metabolome
timeFrame: 0-3.5 Years Corrected Gestational Age
measure: Perinatal factors and microbiome, metabolome and immunobiome
timeFrame: 0-3.5 Years Corrected Gestational Age
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Marie-Claire Arrieta, PhD
role: PRINCIPAL_INVESTIGATOR
References: