Clinical trial NCT06537622: Best Practices Fo Early Diagnosis of Cerebral Palsy
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Prematurity
Keywords: Corrected age
very preterm infants
Developmental functioning
Guideline
Diagnosis
Randomized controlled trial
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
name: St. Boniface Hospital
name: Sunnybrook Health Sciences Centre
name: Montreal Children's Hospital of the MUHC
name: Harvard University
name: University of British Columbia
name: Queen Alexandra Centre for Children's Health, Victoria
name: Jewish General Hospital
name: CHU de Quebec-Universite Laval
name: BC Women's Hospital & Health Centre
name: Dr. Everett Chalmers Hospital
name: Janeway Children's Health and Rehabilitation Centre
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Horizon Health Network
name: Moncton hospital
name: Windsor Regional Hospital
name: Maisonneuve-Rosemont Hospital
name: The Hospital for Sick Children
name: MOUNT SINAI HOSPITAL
name: Health Sciences Centre, Winnipeg, Manitoba
name: Glenrose Foundation
name: Hamilton Health Sciences Centre
name: London Health Sciences Centre
name: Children's Hospital of Eastern Ontario
name: Kingston Health Sciences Centre
name: Foothills Medical Centre
name: Island Health, Victoria, BC
name: Canadian Premature babies Foundation
First posted: 2024-08-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CNFUN sites are the unit of randomization to the order in which they receive the implementation strategy
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intervention : corrected age at detection of early signs of CP.
timeFrame: Birth to 18-24 months CA
measure: Intervention : Developmental functioning at 18-24 month CA
timeFrame: Birth to 18-24 months CA
Secondary outcomes:
measure: Implementation : RE-AIM framework - Reach, Effectiveness, Adoption
timeFrame: Up to 48 months
measure: Implementation : RE-AIM framework - Implementation
timeFrame: Up to 48 months
measure: Implementation : RE-AIM framework - Maintenance
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: CHU Sainte-Justine hospital
name: Luu Thuy Mai, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: