Infant, PrematureBLOOM-PTNNCT03840980
The Alberta BLOOM Preterm Neonate Study
An observational study of Infant, Premature and Infants, Extremely Premature, run by University of Calgary at 1 site in Canada.
Trial summary
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation. The purpose of this study is to gain a thorough understanding of the microbiome (the collection of microbes in a biological site) establishment in very preterm infants. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infant, Premature, Infants, Extremely Premature, Microbiota
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Due to the observational nature of this study and the need to understand early microbiome assembly in all very preterm babies, regardless of the pregnancy complication that led to their premature birth, this study aims to recruit most very preterm neonates that are expected to survive more than one week. Neonates with congenital gastrointestinal anomalies or that have a history of gastrointestinal surgery, will be excluded as these conditions severely affect the microbiome; however the microbiome will not have contributed to the development of these conditions. Participants must reside in the Calgary Metropolitan Region in order to ensure that they can be followed for study participation if transferred to a level II NICU or discharged to home. Only mothers able to legally consent to study participation for themselves and their neonate are eligible to participate in the study.
Infant Inclusion Criteria:
- Born within previous 72 hours;
- Born at ≤ 31 weeks + 6 days gestation (31 6/7 weeks);
- Expected to survive more than 1 week;
- Admitted into the Neonatal Intensive Care Unit at Foothills Medical Centre, Calgary, Alberta;
- Have no major congenital or chromosomal anomalies.
Mother Inclusion Criteria
- Provide a signed and dated informed consent form;
- Able to speak and understand English;
- 16 years of age or older (if 16 or 17 years of age, must be documented in the patient's health record to be a mature minor / competent to provide consent);
- Willing to comply with all study procedures and be available for the duration of the study;
- Reside within the Calgary Metropolitan Region.
Infant Exclusion Criteria
- Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.
Mother Exclusion Criteria
- Not the legal guardian of the baby or
- In a legal guardianship dispute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Alberta BLOOM Preterm Neonate Study: The Impact of Perinatal Factors on the Microbiome, Immunobiome, and Metabolome of Preterm Neonates
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation. The purpose of this study is to gain a thorough understanding of the microbiome (the collection of microbes in a biological site) establishment in very preterm infants. The study will also examine the perinatal factors associated with the pattern of microbiome development, the metabolome and immune development of this population in the first months of life.
All participants will be recruited from the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre (FMC) in Calgary, Alberta, Canada.
Read more
Premature birth (birth before 37 weeks of pregnancy) occurs in about one in ten pregnancies each year. Babies that are born after less than 32 weeks of pregnancy are considered to be very premature babies. When babies are born very 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 babies are more likely to have changes in their gut microbiome that are associated with health issues. However, sciences has not yet discovered what specific microbiome features are involved in development of premature babies. Therefore, this study examines the impact of very premature birth on the premature baby's microbiome.
The kind of microbes that make up the microbiome in the 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 in first months of life that can impact the microbiome development. These factors include diet, exposure to antibiotics, surgical procedures, and birth mode. This study will investigate how these factors influence the types of early microbes present in preterm infants.
The hypothesis of the study is that specific microbial patterns, trajectories and/or metabolites will be significantly associated with single or a combination of perinatal maternal and/or infant factors.
The primary objective of the study is to learn more about the development of the microbiome in very premature babies in the first months of their life. To do this, participating baby's stool and urine samples will be studied.
A secondary objective of the study is to find out how environmental factors impact the development of the microbiome and the health of preterm infants. In order to do this, maternal microbiome samples will be studied and information regarding maternal health, nutrition and environment during pregnancy will be collected. As well, information about the birth and health of participating preterm neonates will be collected.
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
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 through to 60 days of age.
Measured: First 5-6 months of life
Microbiome Assembly
Changes in fecal microbial diversity and microbial population structures from birth through to 60 days of age for all participants as assessed by shotgun metagenomics.
Measured: First 5-6 months of life
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 through to 60 days of age.
Measured: First 5-6 months of life
Immunobiome
Immune analysis of cytokines and chemokines as assessed by mesoscale system for participants with suspected infection such as NEC or neonatal sepsis in the 60 days of study participation.
Measured: First 5-6 months of life
Secondary outcomes (1)
Perinatal factors and microbiome, metabolome and immunobiome.
Association between perinatal factors (environment, nutrition, pharmacological exposure), preterm delivery and the patterns of microbiome, metabolome and immunobiome development as assessed by metagenomics, metabolomics and mesoscale analysis for all participants in the first 60 days of life.
Measured: first 5-6 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 Jan 2019
- Primary completion31 Dec 2021
- Study completion28 Feb 2022
Why it stopped: The BLOOM-PTN study has evolved into the ongoing BLOOM-PCS study (REB20-1442)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Economic Development and Trade, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Marie-Claire Arrieta, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840980
- Sponsor's protocol ID
- REB17-1877
- Acronym
- BLOOM-PTN
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2018
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alberta BLOOM Preterm Neonate Study: The Impact of Perinatal Factors on the Microbiome, Immunobiome, and Metabolome of Preterm Neonates
- ClinicalTrials.gov ID
- NCT03840980
- Acronym / sponsor ID
- BLOOM-PTN / REB17-1877
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The BLOOM-PTN study has evolved into the ongoing BLOOM-PCS study (REB20-1442)
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Economic Development and Trade, Canadian Institutes of Health Research (CIHR)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation. The purpose of this study is to gain a thorough understanding of the microbiome (the collection of microbes in a biological site) establishment in very preterm infants. The study will also examine the perinatal factors associated with the pattern of microbiome development, the metabolome and immune development of this population in the first months of life.
All participants will be recruited from the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre (FMC) in Calgary, Alberta, Canada.
Premature birth (birth before 37 weeks of pregnancy) occurs in about one in ten pregnancies each year. Babies that are born after less than 32 weeks of pregnancy are considered to be very premature babies. When babies are born very 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 babies are more likely to have changes in their gut microbiome that are associated with health issues. However, sciences has not yet discovered what specific microbiome features are involved in development of premature babies. Therefore, this study examines the impact of very premature birth on the premature baby's microbiome.
The kind of microbes that make up the microbiome in the 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 in first months of life that can impact the microbiome development. These factors include diet, exposure to antibiotics, surgical procedures, and birth mode. This study will investigate how these factors influence the types of early microbes present in preterm infants.
The hypothesis of the study is that specific microbial patterns, trajectories and/or metabolites will be significantly associated with single or a combination of perinatal maternal and/or infant factors.
The primary objective of the study is to learn more about the development of the microbiome in very premature babies in the first months of their life. To do this, participating baby's stool and urine samples will be studied.
A secondary objective of the study is to find out how environmental factors impact the development of the microbiome and the health of preterm infants. In order to do this, maternal microbiome samples will be studied and information regarding maternal health, nutrition and environment during pregnancy will be collected. As well, information about the birth and health of participating preterm neonates will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Due to the observational nature of this study and the need to understand early microbiome assembly in all very preterm babies, regardless of the pregnancy complication that led to their premature birth, this study aims to recruit most very preterm neonates that are expected to survive more than one week. Neonates with congenital gastrointestinal anomalies or that have a history of gastrointestinal surgery, will be excluded as these conditions severely affect the microbiome; however the microbiome will not have contributed to the development of these conditions. Participants must reside in the Calgary Metropolitan Region in order to ensure that they can be followed for study participation if transferred to a level II NICU or discharged to home. Only mothers able to legally consent to study participation for themselves and their neonate are eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome
Time frame: First 5-6 months of life
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 through to 60 days of age.
Microbiome Assembly
Time frame: First 5-6 months of life
Changes in fecal microbial diversity and microbial population structures from birth through to 60 days of age for all participants as assessed by shotgun metagenomics.
Metabolome
Time frame: First 5-6 months of life
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 through to 60 days of age.
Immunobiome
Time frame: First 5-6 months of life
Immune analysis of cytokines and chemokines as assessed by mesoscale system for participants with suspected infection such as NEC or neonatal sepsis in the 60 days of study participation.
1 secondary outcome
Perinatal factors and microbiome, metabolome and immunobiome.
Time frame: first 5-6 months of life
Results and safety
The study was stopped early (reason given: The BLOOM-PTN study has evolved into the ongoing BLOOM-PCS study (REB20-1442)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 42612036Asbury 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.
- Alberta BLOOM Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Claire Arrieta, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature and Infants, Extremely Premature, 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?
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: stopped early, as of the sponsor's last update on 4 Apr 2022. 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?
The study was stopped early (reason given: The BLOOM-PTN study has evolved into the ongoing BLOOM-PCS study (REB20-1442)). Results are not available in the source record.
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?
Microbiome (time frame: First 5-6 months of life). The study lists 4 primary outcomes in all. 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 NCT03840980, 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 4 Apr 2022.