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Best Practices Fo Early Diagnosis of Cerebral Palsy

Implementation of Best Practices for Early Diagnosis of Cerebral Palsy (CP) in Very Preterm Infants: a Stepped-wedge Cluster Randomized Controlled Trial (RCT)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06537622
Acronym
CP
Enrollment
2000
Registered
2024-08-05
Start date
2025-02-01
Completion date
2028-11-01
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Prematurity

Keywords

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

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.

Interventions

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

OTHERStandard of care

No active implementation strategies

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
2 Months to 30 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Intervention : corrected age at detection of early signs of CP.Birth to 18-24 months CAThis 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 CABirth to 18-24 months CAEvaluation 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).

Secondary

MeasureTime frameDescription
Implementation : RE-AIM framework - Reach, Effectiveness, AdoptionUp to 48 monthsReach of the intervention strategies to the target audience of clinicians participating in the CNFUN.
Implementation : RE-AIM framework - ImplementationUp to 48 monthsImplementation fidelity to the CPG-CP and the implementation strategies.
Implementation : RE-AIM framework - MaintenanceUp to 48 monthsMaintenance of the practice of CPG-CP over time.

Countries

Canada

Contacts

Primary ContactThuy Mai Luu, MD M.Sc.
thuy.mai.luu@umontreal.ca514-345-4931
Backup ContactAnik Cloutier, M.Sc. CCRP
anik.cloutier2.hsj@ssss.gouv.qc.ca514-345-4931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026