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NCT Number: NCT06537622

Best Practices Fo Early Diagnosis of Cerebral Palsy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implementation group

Other

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

Standard of care

Other

No active implementation strategies

Primary outcomes

  1. Intervention : corrected age at detection of early signs of CP.

    Time frame: Birth to 18-24 months CA

    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.

  2. Intervention : Developmental functioning at 18-24 month CA

    Time frame: Birth to 18-24 months 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).

Secondary outcomes

  1. Implementation : RE-AIM framework - Reach, Effectiveness, Adoption

    Time frame: Up to 48 months

    Reach of the intervention strategies to the target audience of clinicians participating in the CNFUN.

  2. Implementation : RE-AIM framework - Implementation

    Time frame: Up to 48 months

    Implementation fidelity to the CPG-CP and the implementation strategies.

  3. Implementation : RE-AIM framework - Maintenance

    Time frame: Up to 48 months

    Maintenance of the practice of CPG-CP over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Anik Cloutier, M.Sc. CCRP

CONTACT

[email protected]

514-345-4931 ext. 6146

Thuy Mai Luu, MD M.Sc.

CONTACT

[email protected]

514-345-4931 ext. 6642

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CP

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 5, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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