Cerebral PalsyCPNCT06537622
Best Practices Fo Early Diagnosis of Cerebral Palsy
A study testing Implementation group in people with Cerebral Palsy and Prematurity, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e. what is being implemented) in neonatal follow-up clinics across Canada. Read more about this study
- Who is it for?
- Ages 2 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Prematurity
- What is being tested?
- Implementation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2025to 1 Nov 2028
- 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 2 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born preterm at less than 29 weeks' GA and their parents
- Admission to a Neonatal Intensive Care Unit (NICU) participating in the Canadian Neonatal Network (CNN).
Who cannot join
- Death prior to first visit in clinic
- Major congenital malformation and/or significant chromosomal defects affecting development beyond preterm birth
- Child moved outside Canada prior to first visit in clinic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of Best Practices for Early Diagnosis of Cerebral Palsy (CP) in Very Preterm Infants: a Stepped-wedge Cluster Randomized Controlled Trial (RCT)
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e. what is being implemented) in neonatal follow-up clinics across Canada. This clinical practice guideline should be part of what neonatal follow-up specialists do in their routine clinical work with children born preterm. However, there is a wide variability in practice. The goal of this project is to harmonize practices in the neonatal follow-up community in agreement with international recommendations for earlier diagnosis of cerebral palsy. This research will measure if clinicians are truly following the clinical practice guideline. If not, implementation strategies that address barriers and leverage on facilitators will be deployed for successful uptake of the clinical practice guideline. This research will also assess whether implementation of the clinical practice guideline is associated with better patient outcomes.
Read the detailed description
Children born preterm have an increased risk for brain-based disabilities, including cerebral palsy (CP), with lower gestational age (GA) incurring higher vulnerability. The rate of CP in very preterm children born before 29 weeks' GA is 6.1%.The 2017 international recommendations for Early, accurate diagnosis and early intervention in CP provides an evidence-based approach for prompt referral to targeted services to optimize child outcomes. Early diagnosis and intervention during the optimal window of brain plasticity has the potential to improve developmental functioning. Best practice guidelines also exist on how to convey an early diagnosis of CP in a compassionate way, as poor communication can affect parental mental health. The Canadian Neonatal Follow-Up Network (CNFUN) has partnered with the parent-led Canadian Premature Babies Foundation (CPBF) and key stakeholders to adapt these clinical practice guidelines to the Canadian context (CPG-CP). These CPG-CP promote the use of the General Movement Assessment (GMA) and the Hammersmith Infant Neurological Examination (HINE) for identification of early signs of CP. The CPG-CP also propose clinical care pathways and an approach for communicating findings. The overall goal of the CPG-CP is to improve clinicians' ability to accurately recognize the earliest signs of CP that warrant immediate actions (as opposed to a wait-and-see approach). Using a hybrid effectiveness-implementation trial design, the investigators will assess whether the implementation strategy is successful in increasing the uptake of the CPG-CP by CNFUN programs. Concurrently, the investigators will test the effectiveness of implementing the CPG-CP in detecting early signs of CP at a younger age in preterm infants born <29 weeks' GA. The investigators will secondarily compare whether using both the GMA and HINE is more performant than the HINE alone in identifying early signs of CP. Finally, the investigators will examine whether developmental functioning at 18-24 months corrected age (CA) improves after CPG-CP implementation.
This proposal aims to reduce the gap in care related to the early identification of CP in children born very preterm across Canada. Using a hybrid effectiveness-implementation study design, the investigators will implement the CPG-CP in the real-world setting of CNFUN sites, to improve clinicians' ability to detect the early signs of CP in very preterm infants. Early diagnosis enables the initiation of targeted interventions and engagement of support services. Harnessing neuroplasticity through early and specific therapy can improve children's overall development and functioning. The effectiveness of the CPG-CP on improving clinical outcomes relies on a successful implementation process that considers the interplay between inner (i.e., within neonatal follow-up programs), outer (e.g., local health care system), and individual patient and clinician characteristics.
- Conditions
- Cerebral Palsy, Prematurity
- Being tested
- Implementation group, Standard of care
- Keywords
- Corrected age, very preterm infants, Developmental functioning, Guideline, Diagnosis, Randomized controlled trial
- Medical subject headings
- Cerebral Palsy, Premature Birth, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation groupOther
Implementation strategies to increase uptake of the clinical practice guidelines for earlier diagnosis of cerebral palsy
Standard of careOther
No active implementation strategies
| Study group | Role | What they receive |
|---|---|---|
| Intervention aim | Other | To assess the effectiveness of the clinical practice guideline - cerebral palsy detecting early signs of CP at a younger age. More specifically, to reduce the age at detecting early signs of CP from an estimated CA of 11 months (prior to CPG-CP implementation) to 8 months. To determine whether using both the general movement assessment and Hammersmith infant neurological examination is more performant than the HINE alone in identifying early signs of CP. To examine if CPG-CP implementation is associated with better developmental functioning at 18-24 months CA. Receives: Other: Implementation group |
| Implementation aim | Other | Using the RE-AIM framework : To assess REAch of the intervention strategies to the target audience of clinicians in CNFUN programs.To assess Implementation fidelity to the CPG-CP and the implementation strategies. To assess Maintenance of the CPG-CP over time. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention : corrected age at detection of early signs of CP.
This is calculated from the date at which the clinician identifies early signs of CP and shares this diagnosis with family. This diagnosis must be followed by an immediate action i.e., referral for CP-targeted intervention and/or evaluation. Outcome data will be collected through retrospective chart review.
Measured: Birth to 18-24 months CA
Intervention : Developmental functioning at 18-24 month CA
Evaluation of the developmental functioning using the Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4), a widely used, standardized, norm-referenced instrument for direct assessment of children aged 1-42 mo. Cognition, language, and motor composite scores are obtained (mean 100±15).
Measured: Birth to 18-24 months CA
Secondary outcomes (3)
Implementation : RE-AIM framework - Reach, Effectiveness, Adoption
Reach of the intervention strategies to the target audience of clinicians participating in the CNFUN.
Measured: Up to 48 months
Implementation : RE-AIM framework - Implementation
Implementation fidelity to the CPG-CP and the implementation strategies.
Measured: Up to 48 months
Implementation : RE-AIM framework - Maintenance
Maintenance of the practice of CPG-CP over time.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CNFUN sites are the unit of randomization to the order in which they receive the implementation strategy
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre, St. Boniface Hospital, Sunnybrook Health Sciences Centre, Montreal Children's Hospital of the MUHC, Harvard University, University of British Columbia, Queen Alexandra Centre for Children's Health, Victoria, Jewish General Hospital, CHU de Quebec-Universite Laval, BC Women's Hospital & Health Centre, Dr. Everett Chalmers Hospital, Janeway Children's Health and Rehabilitation Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Horizon Health Network, Moncton hospital, Windsor Regional Hospital, Maisonneuve-Rosemont Hospital, The Hospital for Sick Children, MOUNT SINAI HOSPITAL, Health Sciences Centre, Winnipeg, Manitoba, Glenrose Foundation, Hamilton Health Sciences Centre, London Health Sciences Centre, Children's Hospital of Eastern Ontario, Kingston Health Sciences Centre, Foothills Medical Centre, Island Health, Victoria, BC, Canadian Premature babies Foundation
- Responsible party
- Principal investigator, Thuy Mai Luu, St. Justine's Hospital
- Investigators
- Luu Thuy Mai, MD, M.Sc., Principal investigator, CHU Sainte-Justine hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537622
- Sponsor's protocol ID
- MP-21-2024-7044
- Acronym
- CP
- Status last verified
- Dec 2024
- First submitted
- 10 Jul 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will not be available for sharing. Only aggregated data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Best Practices for Early Diagnosis of Cerebral Palsy (CP) in Very Preterm Infants: a Stepped-wedge Cluster Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT06537622
- Acronym / sponsor ID
- CP / MP-21-2024-7044
- Conditions
- Cerebral Palsy, Prematurity
- Keywords
- Corrected age, very preterm infants, Developmental functioning, Guideline, Diagnosis, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- IWK Health Centre, St. Boniface Hospital, Sunnybrook Health Sciences Centre, Montreal Children's Hospital of the MUHC, Harvard University, University of British Columbia, Queen Alexandra Centre for Children's Health, Victoria, Jewish General Hospital, CHU de Quebec-Universite Laval, BC Women's Hospital & Health Centre, Dr. Everett Chalmers Hospital, Janeway Children's Health and Rehabilitation Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Horizon Health Network, Moncton hospital, Windsor Regional Hospital, Maisonneuve-Rosemont Hospital, The Hospital for Sick Children, MOUNT SINAI HOSPITAL, Health Sciences Centre, Winnipeg, Manitoba, Glenrose Foundation, Hamilton Health Sciences Centre, London Health Sciences Centre, Children's Hospital of Eastern Ontario, Kingston Health Sciences Centre, Foothills Medical Centre, Island Health, Victoria, BC, Canadian Premature babies Foundation
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 5 Aug 2024 (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.
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e. what is being implemented) in neonatal follow-up clinics across Canada. This clinical practice guideline should be part of what neonatal follow-up specialists do in their routine clinical work with children born preterm. However, there is a wide variability in practice. The goal of this project is to harmonize practices in the neonatal follow-up community in agreement with international recommendations for earlier diagnosis of cerebral palsy. This research will measure if clinicians are truly following the clinical practice guideline. If not, implementation strategies that address barriers and leverage on facilitators will be deployed for successful uptake of the clinical practice guideline. This research will also assess whether implementation of the clinical practice guideline is associated with better patient outcomes.
Detailed description
Children born preterm have an increased risk for brain-based disabilities, including cerebral palsy (CP), with lower gestational age (GA) incurring higher vulnerability. The rate of CP in very preterm children born before 29 weeks' GA is 6.1%.The 2017 international recommendations for Early, accurate diagnosis and early intervention in CP provides an evidence-based approach for prompt referral to targeted services to optimize child outcomes. Early diagnosis and intervention during the optimal window of brain plasticity has the potential to improve developmental functioning. Best practice guidelines also exist on how to convey an early diagnosis of CP in a compassionate way, as poor communication can affect parental mental health. The Canadian Neonatal Follow-Up Network (CNFUN) has partnered with the parent-led Canadian Premature Babies Foundation (CPBF) and key stakeholders to adapt these clinical practice guidelines to the Canadian context (CPG-CP). These CPG-CP promote the use of the General Movement Assessment (GMA) and the Hammersmith Infant Neurological Examination (HINE) for identification of early signs of CP. The CPG-CP also propose clinical care pathways and an approach for communicating findings. The overall goal of the CPG-CP is to improve clinicians' ability to accurately recognize the earliest signs of CP that warrant immediate actions (as opposed to a wait-and-see approach). Using a hybrid effectiveness-implementation trial design, the investigators will assess whether the implementation strategy is successful in increasing the uptake of the CPG-CP by CNFUN programs. Concurrently, the investigators will test the effectiveness of implementing the CPG-CP in detecting early signs of CP at a younger age in preterm infants born <29 weeks' GA. The investigators will secondarily compare whether using both the GMA and HINE is more performant than the HINE alone in identifying early signs of CP. Finally, the investigators will examine whether developmental functioning at 18-24 months corrected age (CA) improves after CPG-CP implementation.
This proposal aims to reduce the gap in care related to the early identification of CP in children born very preterm across Canada. Using a hybrid effectiveness-implementation study design, the investigators will implement the CPG-CP in the real-world setting of CNFUN sites, to improve clinicians' ability to detect the early signs of CP in very preterm infants. Early diagnosis enables the initiation of targeted interventions and engagement of support services. Harnessing neuroplasticity through early and specific therapy can improve children's overall development and functioning. The effectiveness of the CPG-CP on improving clinical outcomes relies on a successful implementation process that considers the interplay between inner (i.e., within neonatal follow-up programs), outer (e.g., local health care system), and individual patient and clinician characteristics.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CNFUN sites are the unit of randomization to the order in which they receive the implementation strategy
| Arm | Type | Receives |
|---|---|---|
| Intervention aim | Other | Other: Implementation groupTo assess the effectiveness of the clinical practice guideline - cerebral palsy detecting early signs of CP at a younger age. More specifically, to reduce the age at detecting early signs of CP from an estimated CA of 11 months (prior to CPG-CP implementation) to 8 months. To determine whether using both the general movement assessment and Hammersmith infant neurological examination is more performant than the HINE alone in identifying early signs of CP. To examine if CPG-CP implementation is associated with better developmental functioning at 18-24 months CA. |
| Implementation aim | Other | Other: Standard of careUsing the RE-AIM framework : To assess REAch of the intervention strategies to the target audience of clinicians in CNFUN programs.To assess Implementation fidelity to the CPG-CP and the implementation strategies. To assess Maintenance of the CPG-CP over time. |
Who may qualify
- Ages
- 2 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born preterm at less than 29 weeks' GA and their parents
- Admission to a Neonatal Intensive Care Unit (NICU) participating in the Canadian Neonatal Network (CNN).
Key exclusion criteria (3 listed)
- Death prior to first visit in clinic
- Major congenital malformation and/or significant chromosomal defects affecting development beyond preterm birth
- Child moved outside Canada prior to first visit in clinic.
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 |
|---|---|---|
| Implementation groupImplementation strategies to increase uptake of the clinical practice guidelines for earlier diagnosis of cerebral palsy | Other | Intervention aim |
| Standard of careNo active implementation strategies | Other | Implementation aim |
Primary outcome
Intervention : corrected age at detection of early signs of CP.
Time frame: Birth to 18-24 months CA
This is calculated from the date at which the clinician identifies early signs of CP and shares this diagnosis with family. This diagnosis must be followed by an immediate action i.e., referral for CP-targeted intervention and/or evaluation. Outcome data will be collected through retrospective chart review.
Intervention : Developmental functioning at 18-24 month CA
Time frame: Birth to 18-24 months CA
Evaluation of the developmental functioning using the Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4), a widely used, standardized, norm-referenced instrument for direct assessment of children aged 1-42 mo. Cognition, language, and motor composite scores are obtained (mean 100±15).
3 secondary outcomes
Implementation : RE-AIM framework - Reach, Effectiveness, Adoption
Time frame: Up to 48 months
Implementation : RE-AIM framework - Implementation
Time frame: Up to 48 months
Implementation : RE-AIM framework - Maintenance
Time frame: Up to 48 months
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 Dec 2024.
- Individual participant dataSharing planned: Yes. Individual patient data will not be available for sharing. Only aggregated data can be shared.
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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.
Luu Thuy Mai, MD, M.Sc. principal investigator
CHU Sainte-Justine hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation group in people with Cerebral Palsy and Prematurity, run by St. Justine's Hospital at 1 site 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 3 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: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Thuy Mai Luu, MD M.Sc. (514-345-4931 ext. 6642, thuy.mai.luu@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention : corrected age at detection of early signs of CP. (time frame: Birth to 18-24 months CA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.