Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)

Not Applicable

Recruiting

• Conditions: Length of Stay

• Registration Number: NCT05231200
• Lead Sponsor: University of Calgary

Brief Summary

The ABC-QI Trial aims to implement collaborative quality improvement (QI) strategies to standardize care for 32-36 week infants in Level 2 and 3 Neonatal intensive care units (NICUs) across the province of Alberta. The investigators want to know if using validated quality improvement methods and evidence-based care bundles will decrease the duration of hospital stay and get babies home as quickly as possible.

Detailed Description

A stepped-wedge cluster randomized trial will be conducted in 12 NICUs across Alberta (10 Level II and 2 Level III). Each NICU is considered a cluster and will be randomized to transition to the intervention arm at one of three time points.

The planned trial interventions include:

Intervention arm (Collaborative QI Strategies): The study intervention is a constellation of collaborative QI strategies: 1) QI Team Building; 2) QI Education; 3) Implementation of 2 standardized practice care bundles (Respiratory Care, and Nutritional Care); 4) QI mentoring; and 5) Collaborative networking. Based on the randomization, 4 NICUs will transition to the intervention arm at the end of each year.

Control arm (current management): All participating NICUs will be in the control arm during the first year prior to randomization to create a baseline of the current practices and between-units variation. NICUs in the control arm can continue conducting QI activities relevant to current practice, but without receiving the interventions outlined above.

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Study Start: 2023-05-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Length of Stay	Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	The duration of hospitalization until final discharge.

Secondary Outcome Measures

Name	Time	Method
Surfactant administration	First 168 hours of age.	Date and method of administration
Cost to healthcare system per participant	Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	The investigators will use the Canadian Institute for Health Information Patient Cost Estimator to calculate the daily cost based on the Case Mix Groups for gestational age and birth weight.
Number of participants with Hypothermia	Within 1 hour of birth	Axillary temperature \<36.5°C.
Duration of respiratory support	Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	Total number of days administered
Head circumference in centimeters	At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).	actual values in centimeters
Breastmilk use	Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	Defined as number of feeds where infant received breastfeeding or maternal expressed breastmilk
Hospital mortality	Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	Proportion of infants who dies before first discharge home
Transfer from Level II to Level III NICU	Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	Proportion of infants who require escalation of care and transfer to Level III NICU.
Time to regain birth weight	Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	Difference in days between birth date and date when the infants regains or exceeds birth weight after initial weight loss.
Length in centimeters	At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).	actual values in centimeters
Number of emergency room visits per participant	Within 30 days after discharge home	Emergency room visits to any hospital in Alberta following discharge
Infant mortality before 1 year of corrected age	Before 1 year of corrected age	Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks.
Age at achieving full enteral feeding	Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).	Date when the enteral intake reaches 120 ml/kg/day.
Weight in grams	At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).	actual values in grams
Number of unplanned rehospitalizations per participant	Within 30 days after discharge home	Unplanned readmission to any hospital in Alberta following discharge
Staff perception of collaborative QI (EPIQ) implementation.	Year 2, 3, and 4 of study	Semi-structured interviews with selected sample of staff from each NICU
Number of participants with Hypoglycemia	First 24 hours of age	Blood glucose \<2.6 mmol/L.

Trial Locations

Locations (12)

Peter Lougheed Centre; 🇨🇦 Calgary, Alberta, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Rockyview General Hospital; 🇨🇦 Calgary, Alberta, Canada

South Health Campus; 🇨🇦 Calgary, Alberta, Canada

Grande Prairie Regional Hospital; 🇨🇦 Calgary, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Misericordia Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Sturgeon Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Chinook Regional Hospital; 🇨🇦 Lethbridge, Alberta, Canada

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