Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05231200

Conditions

Length of Stay

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

QI Team Building

QI education

Standardized care bundle- respiratory care

Standardized care bundle- nutritional care

QI mentoring

Study Details

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.

Conditions

Length of Stay

Study ID

NCT05231200

Start date

May 1, 2023

Status verified date

Jul, 2025

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

9500 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Control Arm- Current management

NICUs in the control arm can continue conducting QI activities relevant to current practice and current standard of care, but without receiving the interventions until they transition to the intervention arm.

experimental: Intervention Arm- Collaborative Quality implementation 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.

Interventions

QI Team Building

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

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

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

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

Standardized care bundle- nutritional care

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

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

QI mentoring

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

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

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 outcome measure

  • 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). ]

Central Contacts and Locations

Locations

Peter Lougheed Centre

Recruiting

Calgary, Alberta, Canada, T1Y 6J4

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Rockyview General Hospital

Recruiting

Calgary, Alberta, Canada, T2V 1P9

South Health Campus

Recruiting

Calgary, Alberta, Canada, T3M 1M4

Grande Prairie Regional Hospital

Recruiting

Calgary, Alberta, Canada, T8V 4B1

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Misericordia Community Hospital

Recruiting

Edmonton, Alberta, Canada, T5R 4H5

Grey Nuns Community Hospital

Recruiting

Edmonton, Alberta, Canada, T6L 5X8

Sturgeon Community Hospital

Recruiting

Edmonton, Alberta, Canada, T8N 6C4

Chinook Regional Hospital

Recruiting

Lethbridge, Alberta, Canada, T1J 1W5

Medicine Hat Regional Hospital

Recruiting

Medicine Hat, Alberta, Canada, T1A 4H6

Red Deer Regional Hospital

Recruiting

Red Deer, Alberta, Canada, T4N 4E7

More Information

Sponsor

University of Calgary

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Keywords

  • Preterm infants
  • Evidence-based Practice for Improving Quality
  • Neonatal intensive care units

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-07-18.