Status:
COMPLETED
A Cluster Randomized Controlled Trial of FICare At 18 Months
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Toronto
Conditions:
Premature Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feedi...
Detailed Description
Each year, about 15 million of the world's infants are born preterm (\<37 weeks gestation), and this number is increasing. In Alberta, the preterm birth rate was 8.43% in 2015, representing 4,749 infa...
Eligibility Criteria
Inclusion
- Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation who enrolled in the FICare Alberta Level II NICU cluster controlled trial (cRCT). The FICare cRCT enrolled mothers of any age who have decision making capacity; mothers who are able to speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.
Exclusion
- The FICare Alberta Level II NICU cRCT excluded mothers whose infants have serious congenital or chromosomal anomalies that require surgery, or are receiving palliative care; mothers who are not able to communicate in English; mothers with complex social issues.
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2020
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT03337659
Start Date
September 27 2017
End Date
March 26 2020
Last Update
December 11 2024
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N1N4