Length of StayABC-QINCT05231200
Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)
A study testing QI Team Building, QI education and Standardized care bundle- respiratory care in people with Length of Stay, run by University of Calgary at 12 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 36 weeks
- Conditions the study is for
- Length of Stay
- What is being tested?
- QI Team Building, QI education and Standardized care bundle- respiratory care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,500 participants
- Where
- 12 sitesCanada
- Study dates
- 1 May 2023to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Canada12 sites, 12 recruiting
- Recruiting
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Mahesha Bandara, MSc
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Mahesha Bandara, MSc, 1-403-944-3753, mahesha.yatigalpotht@ucalgary.ca
- Recruiting
Rockyview General Hospital
Calgary, Alberta, T2V 1P9
Mahesha Bandara, MSc
- Recruiting
South Health Campus
Calgary, Alberta, T3M 1M4
Mahesha Bandara, MSc
- Recruiting
Grande Prairie Regional Hospital
Calgary, Alberta, T8V 4B1
Mahesha Bandara, MSc
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Mahesha Bandara, MSc
- Recruiting
Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5
Mahesha Bandara, MSc
- Recruiting
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Mahesha Bandara, MSc
- Recruiting
Sturgeon Community Hospital
Edmonton, Alberta, T8N 6C4
Mahesha Bandara, MSc
- Recruiting
Chinook Regional Hospital
Lethbridge, Alberta, T1J 1W5
Mahesha Bandara, Msc
- Recruiting
Medicine Hat Regional Hospital
Medicine Hat, Alberta, T1A 4H6
Mahesha Bandara, MSc
- Recruiting
Red Deer Regional Hospital
Red Deer, Alberta, T4N 4E7
Mahesha Bandara, MSc
About this study
Official title: Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized 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.
Read the 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.
- Conditions
- Length of Stay
- Being tested
- QI Team Building, QI education, Standardized care bundle- respiratory care, Standardized care bundle- nutritional care, QI mentoring
- Keywords
- Preterm infants, Evidence-based Practice for Improving Quality, Neonatal intensive care units
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI Team BuildingBehavioural
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 educationBehavioural
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 careOther
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 careOther
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 mentoringBehavioural
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 networkingBehavioural
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm- Current management | Active comparator | 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. Receives: Other: Current practice- standard of care |
| Intervention Arm- Collaborative Quality implementation Strategies | Experimental | 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. Receives: Behavioral: QI Team Building; Behavioral: QI education; Other: Standardized care bundle- respiratory care; Other: Standardized care bundle- nutritional care; Behavioral: QI mentoring; Behavioral: Collaborative networking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
The duration of hospitalization until final discharge.
Measured: 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).
Secondary outcomes (17)
Cost to healthcare system per participant
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.
Measured: 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).
Number of participants with Hypothermia
Axillary temperature <36.5°C.
Measured: Within 1 hour of birth
Number of participants with Hypoglycemia
Blood glucose <2.6 mmol/L.
Measured: First 24 hours of age
Surfactant administration
Date and method of administration
Measured: First 168 hours of age.
Duration of respiratory support
Total number of days administered
Measured: 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).
Age at achieving full enteral feeding
Date when the enteral intake reaches 120 ml/kg/day.
Measured: 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).
Time to regain birth weight
Difference in days between birth date and date when the infants regains or exceeds birth weight after initial weight loss.
Measured: 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).
Weight in grams
actual values in grams
Measured: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
Length in centimeters
actual values in centimeters
Measured: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
Head circumference in centimeters
actual values in centimeters
Measured: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
Breastmilk use
Defined as number of feeds where infant received breastfeeding or maternal expressed breastmilk
Measured: 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).
Number of unplanned rehospitalizations per participant
Unplanned readmission to any hospital in Alberta following discharge
Measured: Within 30 days after discharge home
Number of emergency room visits per participant
Emergency room visits to any hospital in Alberta following discharge
Measured: Within 30 days after discharge home
Hospital mortality
Proportion of infants who dies before first discharge home
Measured: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Infant mortality before 1 year of corrected age
Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks.
Measured: Before 1 year of corrected age
Transfer from Level II to Level III NICU
Proportion of infants who require escalation of care and transfer to Level III NICU.
Measured: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Staff perception of collaborative QI (EPIQ) implementation.
Semi-structured interviews with selected sample of staff from each NICU
Measured: Year 2, 3, and 4 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 May 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Length of StayStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A stepped-wedge cluster randomized trial (SW-CRT) design. Each of the 12 participating NICUs (10 Level II and 2 Level III) are considered clusters and will be randomized to transition to the intervention arm at one of three-time points over a period of four years. The first year will be a baseline period where no clusters are exposed to the intervention. Based on the randomization, four NICUs will transition to the intervention arm at the end of each year. All clusters will have transitioned to the intervention arm by the start of year four.
- Masking
- None (open label)
- Enrolment
- 9,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Alberta Health services, Covenant Health, Canada
- Responsible party
- Sponsor
- Investigators
- Ayman Abou Mehrem, MD, Principal investigator, University of CalgaryJennifer Toye, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231200
- Sponsor's protocol ID
- 21-1336
- Other IDs
- 462647
- Acronym
- ABC-QI
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2022
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, the de-identified, archived data will be transmitted to and stored at the Federated Research Data Repository (FRDR), for use by other researchers including those outside of the study.
Publications
Abou Mehrem A, Toye J, Aziz K, Benzies K, Alshaikh B, Johnson D, Faris P, Soraisham A, McNeil D, Al Hamarneh YN, Foss K, Foulston C, Johns C, Zimmermann GL, Zein H, Hendson L, Kumaran K, Price D, Singhal N, Shah PS. Alberta Collaborative Quality Improvement Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI) Trial: a protocol for a multicentre, stepped-wedge cluster randomized trial. CMAJ Open. 2023 May 2;11(3):E397-E403. doi: 10.9778/cmajo.20220177. Print 2023 May-Jun.
PubMed 37130608
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05231200
- Acronym / sponsor ID
- ABC-QI / 21-1336
- Conditions
- Length of Stay
- Keywords
- Preterm infants, Evidence-based Practice for Improving Quality, Neonatal intensive care units
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,500 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta, Alberta Health services, Covenant Health, Canada
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped-wedge cluster randomized trial (SW-CRT) design. Each of the 12 participating NICUs (10 Level II and 2 Level III) are considered clusters and will be randomized to transition to the intervention arm at one of three-time points over a period of four years. The first year will be a baseline period where no clusters are exposed to the intervention. Based on the randomization, four NICUs will transition to the intervention arm at the end of each year. All clusters will have transitioned to the intervention arm by the start of year four.
| Arm | Type | Receives |
|---|---|---|
| Control Arm- Current management | Active comparator | Other: Current practice- standard of careNICUs 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. |
| Intervention Arm- Collaborative Quality implementation Strategies | Experimental | Behavioral: QI Team Building, Behavioral: QI education, Other: Standardized care bundle- respiratory care, Other: Standardized care bundle- nutritional care, Behavioral: QI mentoring, Behavioral: Collaborative networkingThe 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. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Preterm Infants:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QI Team BuildingEach 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. | Behavioural | Intervention Arm- Collaborative Quality implementation Strategies |
| QI educationEach 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. | Behavioural | Intervention Arm- Collaborative Quality implementation Strategies |
| Standardized care bundle- respiratory careA 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. | Other | Intervention Arm- Collaborative Quality implementation Strategies |
| Standardized care bundle- nutritional careA 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. | Other | Intervention Arm- Collaborative Quality implementation Strategies |
| QI mentoringEach 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. | Behavioural | Intervention Arm- Collaborative Quality implementation Strategies |
| Collaborative networkingThe 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. | Behavioural | Intervention Arm- Collaborative Quality implementation Strategies |
| Current practice- standard of careAll 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. | Other | Control Arm- Current management |
Primary outcome
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.
17 secondary outcomes
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).
Number of participants with Hypothermia
Time frame: Within 1 hour of birth
Number of participants with Hypoglycemia
Time frame: First 24 hours of age
Surfactant administration
Time frame: First 168 hours of age.
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).
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).
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).
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).
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).
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).
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).
Number of unplanned rehospitalizations per participant
Time frame: Within 30 days after discharge home
Number of emergency room visits per participant
Time frame: Within 30 days after discharge home
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).
Infant mortality before 1 year of corrected age
Time frame: Before 1 year of corrected age
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).
Staff perception of collaborative QI (EPIQ) implementation.
Time frame: Year 2, 3, and 4 of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 37130608Abou Mehrem A, Toye J, Aziz K, Benzies K, Alshaikh B, Johnson D, Faris P, Soraisham A, McNeil D, Al Hamarneh YN, Foss K, Foulston C, Johns C, Zimmermann GL, Zein H, Hendson L, Kumaran K, Price D, Singhal N, Shah PS. Alberta Collaborative Quality Improvement Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI) Trial: a protocol for a multicentre, stepped-wedge cluster randomized trial. CMAJ Open. 2023 May 2;11(3):E397-E403. doi: 10.9778/cmajo.20220177. Print 2023 May-Jun.
- Individual participant dataSharing planned: Yes. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Federated Research Data Repository (FRDR), for use by other researchers including those outside of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayman Abou Mehrem, MD principal investigator
University of Calgary
Jennifer Toye, MD principal investigator
University of Alberta
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QI Team Building, QI education and Standardized care bundle- respiratory care in people with Length of Stay, run by University of Calgary at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahesha Bandara, MSc (1-403-944-3753, mahesha.yatigalpotht@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.