The Alberta BLOOM Preterm Neonate Study

Terminated

• Conditions: Infant, Premature; Microbiota; Gastrointestinal Microbiome; Infants, Extremely Premature

• Registration Number: NCT03840980
• Lead Sponsor: University of Calgary

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-19
• Study Start: 2019-01-14
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Born within previous 72 hours;
2. Born at ≤ 31 weeks + 6 days gestation (31 6/7 weeks);
3. Expected to survive more than 1 week;
4. Admitted into the Neonatal Intensive Care Unit at Foothills Medical Centre, Calgary, Alberta;
5. Have no major congenital or chromosomal anomalies.

Mother Inclusion Criteria

1. Provide a signed and dated informed consent form;
2. Able to speak and understand English;
3. 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);
4. Willing to comply with all study procedures and be available for the duration of the study;
5. Reside within the Calgary Metropolitan Region.

Infant Exclusion Criteria

1. Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.

Mother Exclusion Criteria

1. Not the legal guardian of the baby or
2. In a legal guardianship dispute.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolome	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.
Microbiome	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	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.
Immunobiome	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.

Secondary Outcome Measures

Name	Time	Method
Perinatal factors and microbiome, metabolome and immunobiome.	first 5-6 months of life	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.

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada