The Alberta BLOOM Preterm Neonate Study

NCT ID: NCT03840980

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2022-02-28

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.

Conditions

Infant, Premature; Infants, Extremely Premature; Microbiota; Gastrointestinal Microbiome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

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.

Exclusion Criteria

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

1. Not the legal guardian of the baby or

2. In a legal guardianship dispute.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Economic Development and Trade

UNKNOWN

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Claire Arrieta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Related Links

http://albertabloom.ca/

Alberta BLOOM Study Website

Other Identifiers

REB17-1877

Identifier Type: -

Identifier Source: org_study_id