The Alberta BLOOM Long Term Follow Up Study

NCT04641000 | Terminated

• 1 other identifier: REB19-1780
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation. The purpose of this study is to investigate the microbiome (the collection of microbes in a biological site) alternations resulting from preterm birth and associations with the risk of immune dysregulation, asthma and allergies.

Conditions

Infant, Premature, Diseases; Infant; Asthma; Asthma in Children; Allergies; Infant, Extremely Premature

Keywords

Microbiota; Microbiome; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (4)

• Microbiome Establishment and Assembly

  Fecal microbial diversity and the relative abundance of bacterial and eukaryotic taxa, as assessed by polymerase chain reaction of the 16S and ITS2 gene and functional analysis on 16S taxonomic surveys for all participants from birth to around 1-year CGA. Changes in fecal microbial diversity and microbial population structures from birth to around 1-year CGA for all participants as assessed by shotgun metagenomics.

  1-2 Years Corrected Gestational Age

• Metabolome

  Human and microbial metabolites as assessed by untargeted metabolomics, ultra-performance liquid chromatography ultrahigh-resolution Fourier transform (FT) combined with mass spectrometry to identify human and microbial metabolites for all participants from birth to around 1-year CGA.

  1-2 Years Corrected Gestational Age

• Asthma Risk

  Health outcomes such as asthma risk that are influenced by novel linkages between gut microbiome features (taxonomical and functional) as assessed by the Asthma Predictive Index, which involves determining history of wheeze, atopic dermatitis, familial history and eosinophilia.

  1-2 Years Corrected Gestational Age

• Allergies

  Skin reactivity to common allergens as assessed by a skin prick test.

  1-2 Years Corrected Gestational Age

Eligibility Criteria

• Age: 1 Year - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study recruits very early preterm infants that previously participated on at least one of the PROBIO, BLOOM PTN or BLOOM PTB studies.

You may qualify if:

• Born at ≤ 31 weeks + 6 days gestation (316/7 weeks);
• Previously participated in the PROBIO and/or BLOOM PTN and/or BLOOM PTB research studies.
• Provide a signed and dated informed consent form.
• Willing and able to attend a clinic visit at Alberta Children's Hospital in Calgary, Alberta.
• Parent/guardian providing consent must be able to speak and understand English.

You may not qualify if:

• Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.
• Has major chromosomal anomalies.

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Infant, Premature, Diseases; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Marie-Claire Arrieta, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 20, 2020
• Primary Completion: August 16, 2021
• Study Completion: March 26, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

CA (1)