Best Practices Fo Early Diagnosis of Cerebral Palsy (CP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy; Prematurity
• Intervention / Treatment: Other: Implementation group; Other: Standard of care

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 Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thuy Mai Luu, MD M.Sc.; Phone Number: 6642 514-345-4931; Email: thuy.mai.luu@umontreal.ca
• Study Contact Backup: Name: Anik Cloutier, M.Sc. CCRP; Phone Number: 6146 514-345-4931; Email: anik.cloutier2.hsj@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention aim; 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.	Other: Implementation group; Implementation strategies to increase uptake of the clinical practice guidelines for earlier diagnosis of cerebral palsy
Other: Implementation aim; 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.	Other: Standard of care; No active implementation strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Birth to 18-24 months CA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation : RE-AIM framework - Reach, Effectiveness, Adoption	Reach of the intervention strategies to the target audience of clinicians participating in the CNFUN.	Up to 48 months
Implementation : RE-AIM framework - Implementation	Implementation fidelity to the CPG-CP and the implementation strategies.	Up to 48 months
Implementation : RE-AIM framework - Maintenance	Maintenance of the practice of CPG-CP over time.	Up to 48 months

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: The Hospital for Sick Children; Sunnybrook Health Sciences Centre; University of British Columbia; Health Sciences Centre, Winnipeg, Manitoba; CHU de Quebec-Universite Laval; Centre de recherche du Centre hospitalier universitaire de Sherbrooke; London Health Sciences Centre; Children's Hospital of Eastern Ontario; Harvard University; Maisonneuve-Rosemont Hospital; Jewish General Hospital; MOUNT SINAI HOSPITAL; IWK Health Centre; Horizon Health Network; St. Boniface Hospital; Glenrose Foundation; Montreal Children's Hospital of the MUHC; Foothills Medical Centre; BC Women's Hospital & Health Centre; Windsor Regional Hospital; Janeway Children's Health and Rehabilitation Centre; Island Health, Victoria, BC; Queen Alexandra Centre for Children's Health, Victoria; Dr. Everett Chalmers Hospital; Moncton hospital; Hamilton Health Sciences Centre; Canadian Premature babies Foundation; Kingston Health Sciences Centre
• Investigators: Principal Investigator: Luu Thuy Mai, MD, M.Sc., CHU Sainte-Justine hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Diagnosis; Guideline; Corrected age; very preterm infants; Developmental functioning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: MP-21-2024-7044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data will not be available for sharing. Only aggregated data can be shared.
• IPD Sharing Time Frame: We will be sharing this material starting in January 2025 as soon as ethics approval has been obtained from all sites until the end of the study.
• IPD Sharing Access Criteria: The individual is affiliated with a non-profit organization or a university-based research institution.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No