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NCT Number: NCT05231200

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

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.

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Key information

Conditions

Age range

32 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QI Team Building

Behavioral

Each NICU will create a core QI team composed of 6-8 multidisciplinary members including a parent advisor, when feasible. This team will lead the QI activities and education, and champion the culture and practice change in the unit.

QI education

Behavioral

Each NICU QI team will receive standardized QI education using the 6-hour EPIQ Workshop which involves hands-on approach to enable teams to successfully implement QI projects together. EPIQ 10 Steps and QI Tools will be used to build the team's understanding of QI using realistic improvement opportunities based on the standardized care bundles identified in the trial.

Standardized care bundle- respiratory care

Other

A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for stabilization and respiratory care in moderate and late preterm infants (MLPIs) including

  • establishing effective ventilation in the delivery room
  • prevention of hypothermia
  • early diagnosis and management of respiratory distress with continuous positive airway pressure (CPAP)
  • standardized approach for surfactant indications and administration
  • standardized approach for early extubation.

Standardized care bundle- nutritional care

Other

A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for nutritional support in MLPIs including

  • early initiation of enteral or parenteral nutrition;
  • standardized tables for feeding initiation and progression
  • optimizing breastfeeding and use of mother's own milk
  • standardized approach for a transition from enteral nutrition via tube feeds to oral feeds.

QI mentoring

Behavioral

Each NICU in the intervention arm will have one or more assigned members of the study team who are experienced in collaborative QI and EPIQ methods. The mentors will help local QI teams to engage frontline staff in QI and navigate the unit-specific challenges.

Collaborative networking

Behavioral

The study team will conduct virtual meetings every 2 months for the NICUs in intervention arm allowing local QI teams to discuss progress, and share data. The investigators will arrange annual in-person or virtual meetings for the NICUs in the intervention arm to present projects, successes, and lessons learned. These NICUs will have continuing access to the data and will receive quarterly reports using statistical process control charts outlining the unit's performance compared to other units and to the group average.

Current practice- standard of care

Other

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 until they transition to the intervention arm. The investigators will capture these activities and account for them in the analysis.

Primary outcomes

  1. Length of Stay

    Time frame: 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 outcomes

  1. Cost to healthcare system per participant

    Time frame: 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.

  2. Number of participants with Hypothermia

    Time frame: Within 1 hour of birth

    Axillary temperature <36.5°C.

  3. Number of participants with Hypoglycemia

    Time frame: First 24 hours of age

    Blood glucose <2.6 mmol/L.

  4. Surfactant administration

    Time frame: First 168 hours of age.

    Date and method of administration

  5. Duration of respiratory support

    Time frame: 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

  6. Age at achieving full enteral feeding

    Time frame: 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.

  7. Time to regain birth weight

    Time frame: 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.

  8. Weight in grams

    Time frame: 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

  9. Length in centimeters

    Time frame: 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

  10. Head circumference in centimeters

    Time frame: 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

  11. Breastmilk use

    Time frame: 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

  12. Number of unplanned rehospitalizations per participant

    Time frame: Within 30 days after discharge home

    Unplanned readmission to any hospital in Alberta following discharge

  13. Number of emergency room visits per participant

    Time frame: Within 30 days after discharge home

    Emergency room visits to any hospital in Alberta following discharge

  14. Hospital mortality

    Time frame: 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

  15. Infant mortality before 1 year of corrected age

    Time frame: Before 1 year of corrected age

    Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks.

  16. Transfer from Level II to Level III NICU

    Time frame: 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.

  17. Staff perception of collaborative QI (EPIQ) implementation.

    Time frame: Year 2, 3, and 4 of study

    Semi-structured interviews with selected sample of staff from each NICU

Study contacts

Contact information is provided by the study sponsor or research team.

Ayman Abou Mehrem, MD

CONTACT

[email protected]

1-403-944-3699

Mahesha Bandara, MSc

CONTACT

[email protected]

1-403-944-3753

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services
  • Covenant Health, Canada
  • University of Alberta

Registry information

Official study title

Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized Trial

Acronym: ABC-QI

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2022
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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