Best Practices Fo Early Diagnosis of Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-30
SponsorSt. Justine's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Implementation group
Other interventionImplementation strategies to increase uptake of the clinical practice guidelines for earlier diagnosis of cerebral palsy
Standard of care
Other interventionNo active implementation strategies
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Intervention aimOther 1 intervention
Group B: Implementation aimOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Birth to 18-24 months CA2
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).
Time frame
Birth to 18-24 months CASecondary outcomes
1
Implementation : RE-AIM framework - Reach, Effectiveness, Adoption
Reach of the intervention strategies to the target audience of clinicians participating in the CNFUN.
Time frame
Up to 48 months2
Implementation : RE-AIM framework - Implementation
Implementation fidelity to the CPG-CP and the implementation strategies.
Time frame
Up to 48 months3
Implementation : RE-AIM framework - Maintenance
Maintenance of the practice of CPG-CP over time.
Time frame
Up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Justine's Hospital
Lead sponsor
IWK Health Centre
Collaborator
St. Boniface Hospital
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
Harvard University
Collaborator
University of British Columbia
Collaborator
Queen Alexandra Centre for Children's Health, Victoria
Collaborator
Jewish General Hospital
Collaborator
CHU de Quebec-Universite Laval
Collaborator
BC Women's Hospital & Health Centre
Collaborator
Dr. Everett Chalmers Hospital
Collaborator
Janeway Children's Health and Rehabilitation Centre
Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborator
Horizon Health Network
Collaborator
Moncton hospital
Collaborator
Windsor Regional Hospital
Collaborator
Maisonneuve-Rosemont Hospital
Collaborator
The Hospital for Sick Children
Collaborator
MOUNT SINAI HOSPITAL
Collaborator
Health Sciences Centre, Winnipeg, Manitoba
Collaborator
Glenrose Foundation
Collaborator
Hamilton Health Sciences Centre
Collaborator
London Health Sciences Centre
Collaborator
Children's Hospital of Eastern Ontario
Collaborator
Kingston Health Sciences Centre
Collaborator
Foothills Medical Centre
Collaborator
Island Health, Victoria, BC
Collaborator
Canadian Premature babies Foundation
Collaborator
Source ClinicalTrials.gov
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