Best Practices Fo Early Diagnosis of Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2028-11-01

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Prematurity

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Implementation group

Intervention Type OTHER

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

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.

Group Type OTHER

Standard of care

Intervention Type OTHER

No active implementation strategies

Interventions

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Implementation group

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

Intervention Type OTHER

Standard of care

No active implementation strategies

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Thuy Mai Luu

Pediatrician, researcher and Medical director of the Canadian Neonatal Follow-up Network (CNFUN)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luu Thuy Mai, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

CHU Sainte-Justine hospital

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Thuy Mai Luu, MD M.Sc.

Role: CONTACT

Phone: 514-345-4931

Email: [email protected]

Anik Cloutier, M.Sc. CCRP

Role: CONTACT

Phone: 514-345-4931

Email: [email protected]

Other Identifiers

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MP-21-2024-7044

Identifier Type: -

Identifier Source: org_study_id

Best Practices Fo Early Diagnosis of Cerebral Palsy

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Intervention aim

Implementation group

Implementation aim

Standard of care

Interventions

Implementation group

Standard of care

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

IWK Health Centre

St. Boniface Hospital

Sunnybrook Health Sciences Centre

Montreal Children's Hospital of the MUHC

Harvard University

University of British Columbia

Queen Alexandra Centre for Children's Health, Victoria

Jewish General Hospital

CHU de Quebec-Universite Laval

BC Women's Hospital & Health Centre

Dr. Everett Chalmers Hospital

Janeway Children's Health and Rehabilitation Centre

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Horizon Health Network

Moncton hospital

Windsor Regional Hospital

Maisonneuve-Rosemont Hospital

The Hospital for Sick Children

MOUNT SINAI HOSPITAL

Health Sciences Centre, Winnipeg, Manitoba

Glenrose Foundation

Hamilton Health Sciences Centre

London Health Sciences Centre

Children's Hospital of Eastern Ontario

Kingston Health Sciences Centre

Foothills Medical Centre

Island Health, Victoria, BC

Canadian Premature babies Foundation

St. Justine's Hospital

Responsible Party

Thuy Mai Luu

Principal Investigators

Luu Thuy Mai, MD, M.Sc.

Locations

CHU Sainte-Justine

Countries

Central Contacts

Thuy Mai Luu, MD M.Sc.

Anik Cloutier, M.Sc. CCRP

Other Identifiers

MP-21-2024-7044