Best Practices Fo Early Diagnosis of Cerebral Palsy

NCT06537622 | Not Yet Recruiting

• 1 other identifier: MP-21-2024-7044
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Prematurity

Keywords

Corrected age; very preterm infants; Developmental functioning; Guideline; Diagnosis; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Implementation : RE-AIM framework - Reach, Effectiveness, Adoption

  Up to 48 months

• Implementation : RE-AIM framework - Implementation

  Up to 48 months

• Implementation : RE-AIM framework - Maintenance

  Up to 48 months

Study Arms (2)

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.

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.

Other: Standard of care

Interventions

Implementation group OTHER

Implementation strategies to increase uptake of the clinical practice guidelines for earlier diagnosis of cerebral palsy

Intervention aim

Standard of care OTHER

No active implementation strategies

Implementation aim

Eligibility Criteria

• Age: 2 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• 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

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Premature Birth; Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Luu Thuy Mai, MD, M.Sc.

  CHU Sainte-Justine hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thuy Mai Luu, MD M.Sc.

CONTACT

514-345-4931; thuy.mai.luu@umontreal.ca

Anik Cloutier, M.Sc. CCRP

CONTACT

514-345-4931; anik.cloutier2.hsj@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, researcher and Medical director of the Canadian Neonatal Follow-up Network (CNFUN)

Model Details: CNFUN sites are the unit of randomization to the order in which they receive the implementation strategy

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 5, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: The individual is affiliated with a non-profit organization or a university-based research institution.

Locations

CA (1)