Improving care for moderate and late preterm infants in Alberta NICUs
Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized Trial
This study is testing a new way to improve care for babies born a bit early in Alberta's NICUs to see if it helps them go home sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9500 (estimated) |
| Ages | 32 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 12 sites (Calgary, Alberta and 11 other locations) |
| Trial ID | NCT05231200 on ClinicalTrials.gov |
What this trial studies
The ABC-QI Trial aims to implement collaborative quality improvement strategies to standardize care for infants born at 32-36 weeks' gestation in neonatal intensive care units across Alberta. This stepped-wedge cluster randomized trial will involve 12 NICUs, where each unit will transition to the intervention arm at different time points. The intervention includes team building, education, and standardized care bundles for respiratory and nutritional care, with the goal of reducing hospital stay duration for preterm infants. The control arm will establish baseline practices before the intervention is introduced.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at 32 to 36 weeks' gestation admitted to participating NICUs.
Not a fit: Patients with major congenital anomalies, those admitted to surgical NICUs, or infants born outside Alberta may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly reduce the length of hospital stays for preterm infants, allowing them to return home sooner.
How similar studies have performed: Other studies utilizing collaborative quality improvement strategies in neonatal care have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Preterm Infants: Infants born at 32 to 36 weeks' gestation and admitted to the participating NICUs or postpartum units. Quality Improvement Implementation Survey version 2 (QIIS-II) and semi-structured interview participants: Management staff, nurses, nurse practitioners, physicians, and allied health staff employed in participating NICUs. Exclusion Criteria: * Preterm Infants: * Major congenital anomalies or chromosomal abnormalities. * Primary admission to a surgical NICU: Alberta Children's Hospital or Stollery Children's Hospital. * Infants born in or transferred to a NICU outside Alberta. * Patients who have imposed confidentiality restrictions on accessing their health records.
Where this trial is running
Calgary, Alberta and 11 other locations
- Peter Lougheed Centre — Calgary, Alberta, Canada (Recruiting)
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- Rockyview General Hospital — Calgary, Alberta, Canada (Recruiting)
- South Health Campus — Calgary, Alberta, Canada (Recruiting)
- Grande Prairie Regional Hospital — Calgary, Alberta, Canada (Recruiting)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
- Misericordia Community Hospital — Edmonton, Alberta, Canada (Recruiting)
- Grey Nuns Community Hospital — Edmonton, Alberta, Canada (Recruiting)
- Sturgeon Community Hospital — Edmonton, Alberta, Canada (Recruiting)
- Chinook Regional Hospital — Lethbridge, Alberta, Canada (Recruiting)
- Medicine Hat Regional Hospital — Medicine Hat, Alberta, Canada (Recruiting)
- Red Deer Regional Hospital — Red Deer, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Ayman Abou Mehrem, MD — University of Calgary
- Study coordinator: Mahesha Bandara, MSc
- Email: mahesha.yatigalpotht@ucalgary.ca
- Phone: 1-403-944-3753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.