Clinical trial NCT03840980: The Alberta BLOOM Preterm Neonate Study
Official title: The Alberta BLOOM Preterm Neonate Study: The Impact of Perinatal Factors on the Microbiome, Immunobiome, and Metabolome of Preterm Neonates
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infant, Premature
Infants, Extremely Premature
Microbiota
Gastrointestinal Microbiome
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Economic Development and Trade
name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-02-15
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Infant 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.

Primary outcomes:
measure: Microbiome
timeFrame: First 5-6 months of life
measure: Microbiome Assembly
timeFrame: First 5-6 months of life
measure: Metabolome
timeFrame: First 5-6 months of life
measure: Immunobiome
timeFrame: First 5-6 months of life
Secondary outcomes:
measure: Perinatal factors and microbiome, metabolome and immunobiome.
timeFrame: first 5-6 months of life
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Marie-Claire Arrieta, PhD
role: PRINCIPAL_INVESTIGATOR
References: