Status:
TERMINATED
The Alberta BLOOM Preterm Neonate Study
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Alberta Economic Development and Trade
Canadian Institutes of Health Research (CIHR)
Conditions:
Infant, Premature
Infants, Extremely Premature
Eligibility:
All Genders
16+ years
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 un...
Eligibility Criteria
Inclusion
- Infant Inclusion Criteria:
- Born within previous 72 hours;
- Born at ≤ 31 weeks + 6 days gestation (31 6/7 weeks);
- Expected to survive more than 1 week;
- Admitted into the Neonatal Intensive Care Unit at Foothills Medical Centre, Calgary, Alberta;
- Have no major congenital or chromosomal anomalies.
- Mother Inclusion Criteria
- Provide a signed and dated informed consent form;
- Able to speak and understand English;
- 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);
- Willing to comply with all study procedures and be available for the duration of the study;
- Reside within the Calgary Metropolitan Region.
- Infant Exclusion Criteria
- 1\) Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.
- Mother Exclusion Criteria
- Not the legal guardian of the baby or
- In a legal guardianship dispute.
Exclusion
Key Trial Info
Start Date :
January 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03840980
Start Date
January 14 2019
End Date
February 28 2022
Last Update
April 4 2022
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9