The Alberta BLOOM Preterm Neonate Study — BLOOM-PTN  

Microbiota Clinical Trial

Official title: The Alberta BLOOM Preterm Neonate Study: The Impact of Perinatal Factors on the Microbiome, Immunobiome, and Metabolome of Preterm Neonates

Status Terminated

Clinical 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. 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Infant, Premature
• Infants, Extremely Premature
• Microbiota
• Premature Birth

• NCT number: NCT03840980
• Study type: Observational
• Source: University of Calgary
• Status: Terminated
• Start date: January 14, 2019
• Completion date: February 28, 2022