The study clinic visit procedures and samples collected throughout the study are analyzed to answer research questions and are not intended as diagnostic. However, if a skin prick test is positive, and Parent/Guardian has provided consent when asked at the time of the visit, we will inform the child’s family physician or pediatrician.
The cash reimbursement and gift cards provided to you as part of your participation are meant to cover expenses for attending the clinic visit(s) and be a gesture of gratitude, respectively, for your time and efforts dedicated to this research study. They in no way should add undue pressure to complete the study components and/or sample collections. You are at liberty to withdraw from the study or decline from completing any study components at any time.
If you choose to participate to the BLOOM Premature Child Study (PCS), you will receive a $50.00 gift card at the start of the study. When you do the first two questionnaires you will receive a $25.00 gift card for each. You will also receive $50.00 in cash at each clinic visit.
For similar questions regarding any other BLOOM studies, please reach out to our clinical research assistant here.
If you agree for you and your child to participate in this study, there will be no direct benefit to your child or you. However, this study may help the researchers learn more about predicting outcomes and providing better treatments for children born premature who develop health outcomes related to the microbiome.
The community of microbes (tiny living things such as bacteria) that make up the microbiome in the first years of life can have a major impact on a child’s health and development. Recent studies have shown that the gut microbiome during infancy can impact the risk of developing asthma. Children born premature are more likely to have changes in their gut microbiome that are associated with asthma and allergies. Despite their increased risk of suffering from asthma, the role of the microbiome in asthma risk is not well understood for children born premature. The Alberta BLOOM Premature Child Study is the first study to research this in Canada.
The Alberta BLOOM Premature Child (PCS) Study:
Infants born in a Calgary, Alberta hospital before 37-weeks gestation and their mothers; or participants of previous studies including Pregnancy During the Pandemic (PdP), BLOOM-LTFU, BLOOM-PTN, and PROBIO will be invited to participate in the Alberta BLOOM Premature Child (PCS) Study. About 405 children born preterm and 130 children born term from Alberta will take part in this study.
The Alberta BLOOM Preterm Birth (PTB) Study:
BLOOM-PTB recruits mothers who present with spontaneous preterm labour or rupture of membranes at Foothills Medical Centre before 32 weeks gestation. Women experiencing healthy pregnancies and those with complications necessitating scheduled preterm deliveries are also recruited for BLOOM-PTB through outpatient clinics associated with the Foothills Medical Centre.
If participating in the BLOOM Premature Child Study (PCS), you and your child will be involved in the study until your baby turns 3.5 years regardless of your child’s age when they joined the study.
Over this period, we will ask you:
To collect samples (stool and urine, breastmilk) at the most 10 times (details in the figure and legend). Sampling is done at home that mostly consists of stool and urine samples (details here).
We will ask you to fill in four questionnaires at your own pace (can be paused and restarted).
Lastly we will welcome you three time at the clinic, a first time for a 15min interview (3 months) and two other times for 30 min clinic visits (1 & 3 years).
While we cannot set a determined time, we estimate that overall your involvement in the study should take less than 10hrs over the whole period of enrolment (inc. on-site visit).
For infants joining at birth – Details about sample collection frequency:
When returning home, we will ask you to collect samples once weekly until your baby reaches 8 weeks.
Details about sample collection
Sample collection is done from the comfort of your home. For sample pick-up, samples will be placed in a provided cooler left at your door. Coolers can be ordered from home by reaching out to our team or our carrier directly (details here). Once ordered, coolers are delivered with sampling materials and instructions at your front door. Cooler delivery and pickup are contactless. The infant’s samples during this period consist of stool and urine collection. Samples collection and “shipping” are thought to take less than 30min. In total, we will ask you at the most 7 sample collection time points within the first 8 weeks of your baby’s age.
For similar questions about the other BLOOM study, please visit their webpage here.
Each sample type (for example, stool, urine, blood) will be examined by thorough scientific methods to obtain valuable information specific to that sample. For example, stool samples will be examined to investigate the gut microbiome establishment, composition, and dynamic by looking at the abundance of the different microbes present over time in the feces. This will help to better understand how the gut microbiome of babies born preterm develops over the first years of life .
Find detailed information about our studies, their goals, cohort, timeline & organization here.
We understand this can be frustrating and are happy to help in this situation. Please reach out to the BLOOM Research Assistant you have been in contact with or the Clinical Research Coordinator (Their contact information can be found here). They will be able to provide you with help and potentially send you more cotton balls to use.
Our BLOOM studies will replace any information that can identify you and your child with a study identification number. All data and samples collected for the study will be kept in secure locations and only accessed by authorized study personnel.
When participating in the BLOOM Premature Child Study (PCS), infants are enrolled until they reach 3.5 yrs old, regardless of the age they joined the study at,
For similar questions about the other BLOOM studies, please visit their webpage here.
Participation is voluntary and you may withdraw at any time. Whether you choose to participate or not will not affect the care you and your child receive.
Absolutely! You can do so by reaching out to one of our coordinators here via email or phone, or reach out directly to our carrier, Fireball, at (403) 265-2004 before 5 PM, Monday through Friday. You will need to provide them with the date and window of time (the courier typically needs a minimum of 3 hours) that you would like the cooler to be picked up at. For same-day pick-up, please call Fireball before 11:00 AM that day.
Cooler pick-up is contactless, simply leave your cooler on your front step at the time you ordered the pick at.