Actively Recruiting
Led by University of Calgary · Updated on 2025-07-18
9500
Participants Needed
12
Research Sites
N/A
Total Duration
U
University of Calgary
Lead Sponsor
U
University of Alberta
Collaborating Sponsor
The trial focuses on moderate and late preterm infants born between 32 and 36 weeks' gestation who are admitted to Level 2 and 3 Neonatal Intensive Care Units (NICUs) across Alberta. Researchers aim to find out if applying collaborative quality improvement methods and standardized care bundles can reduce the length of hospital stays and help babies get home faster. This stepped-wedge cluster randomized trial includes 12 NICUs randomized to adopt the intervention at different times, allowing comparison against current standard care. The intervention involves multiple collaborative quality improvement strategies: building dedicated QI teams in each NICU, providing standardized QI education, implementing two care bundles focused on respiratory and nutritional support, mentoring by experienced QI members, and facilitating collaborative networking with regular virtual and in-person meetings. Participating NICUs will transition from current practices to this intervention in phases over three years. During the control period, NICUs continue their usual care and any ongoing QI activities without the new intervention strategies. Participants' progress will be monitored from birth until discharge or death, with assessments continuing up to six months after their due date. Researchers will track hospital stay length, healthcare costs, respiratory support duration, feeding milestones, growth measurements, rehospitalizations, mortality, and staff perceptions of QI implementation. Data will be collected through clinical records and surveys. The study spans from May 2023 to August 2027, aiming to improve care quality and outcomes for these preterm infants.
CONDITIONS
Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year prior to transitioning to intervention
Participants in NICUs will receive current standard care practices and may participate in quality improvement activities relevant to their unit but without the study interventions until their unit transitions to the intervention arm.
Ongoing clinical care and observations as part of routine NICU management
Duration - Up to 3 years depending on NICU transition timing
Participants in NICUs receive a set of collaborative quality improvement strategies including team building, education, implementation of standardized respiratory and nutritional care bundles, mentoring, and collaborative networking to improve care practices.
Ongoing clinical care and observations as part of routine NICU management
Duration - Up to 6 months after birth due date
Participants are followed until they reach a corrected age of 6 months to assess outcomes such as length of stay, growth, rehospitalizations, and mortality.
Follow-up visits or record reviews occurring periodically until 6 months corrected age
Total: 12 locations
1
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6J4
Actively Recruiting
2
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
3
Rockyview General Hospital
Calgary, Alberta, Canada, T2V 1P9
Actively Recruiting
4
South Health Campus
Calgary, Alberta, Canada, T3M 1M4
Actively Recruiting
5
Grande Prairie Regional Hospital
Calgary, Alberta, Canada, T8V 4B1
Actively Recruiting
6
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Actively Recruiting
7
Misericordia Community Hospital
Edmonton, Alberta, Canada, T5R 4H5
Actively Recruiting
8
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Actively Recruiting
9
Sturgeon Community Hospital
Edmonton, Alberta, Canada, T8N 6C4
Actively Recruiting
10
Chinook Regional Hospital
Lethbridge, Alberta, Canada, T1J 1W5
Actively Recruiting
11
Medicine Hat Regional Hospital
Medicine Hat, Alberta, Canada, T1A 4H6
Actively Recruiting
12
Red Deer Regional Hospital
Red Deer, Alberta, Canada, T4N 4E7
Actively Recruiting
M
Mahesha Bandara, MSc
A
Ayman Abou Mehrem, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Ayman Abou Mehrem, Jennifer Toye, Khalid Aziz...
https://pubmed.ncbi.nlm.nih.gov/37130608