Early Diagnosis Practices for Cerebral Palsy

(CP Trial)

Overseen By Thuy Mai Luu, MD M.Sc.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Death, Major malformation, Moved outside Canada

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Best Practices for Early Diagnosis of Cerebral Palsy?

Research shows that early diagnosis of cerebral palsy (CP) using standardized assessments and brain imaging leads to better motor and cognitive outcomes for children. Implementing guidelines for early detection helps reduce the age at which CP is diagnosed, allowing for timely interventions that improve overall development. ^{1 2 3 4 5}

Is the treatment for early diagnosis of cerebral palsy safe for humans?

The research articles provided do not contain specific safety data related to the early diagnosis practices for cerebral palsy or similar treatments. ^{6 7 8 9 10}

How does the early diagnosis treatment for cerebral palsy differ from other treatments?

This treatment focuses on early diagnosis of cerebral palsy using standardized assessments and brain imaging, allowing for earlier intervention with specialized therapies and family support, which can lead to better motor and cognitive outcomes. Unlike traditional approaches that diagnose CP after 12 months, this method aims to identify the condition by 5 months, optimizing the timing for effective intervention. ^{1 2 11 12 13}

What is the purpose of this trial?

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.

Research Team

Luu Thuy Mai, MD, M.Sc.

Principal Investigator

CHU Sainte-Justine hospital

Eligibility Criteria

This trial is for neonatal follow-up specialists in Canada who work with children born preterm. It aims to standardize the early diagnosis of cerebral palsy according to international guidelines.

Inclusion Criteria

Admission to a Neonatal Intensive Care Unit (NICU) participating in the Canadian Neonatal Network (CNN)

My baby was born before 29 weeks of pregnancy.

Exclusion Criteria

I have a major birth defect or significant genetic issue affecting my development.

Child moved outside Canada prior to first visit in clinic

Death prior to first visit in clinic

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the clinical practice guideline for early diagnosis of cerebral palsy in neonatal follow-up clinics

Up to 48 months

Intervention

Assessment of the effectiveness of the clinical practice guideline in detecting early signs of cerebral palsy and improving developmental functioning

Birth to 18-24 months corrected age

Follow-up

Participants are monitored for developmental functioning and early signs of cerebral palsy

18-24 months corrected age

Treatment Details

Interventions

• Best Practices for Early Diagnosis of Cerebral Palsy

Trial Overview The study tests whether implementing a clinical practice guideline across neonatal clinics leads to more consistent and earlier diagnosis of cerebral palsy in premature infants.

Participant Groups

Group I: Intervention aim Experimental Treatment 1 Intervention

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 II: Implementation aim Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Montreal Children's Hospital of the MUHC

Collaborator

Trials

32

Recruited

117,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Maisonneuve-Rosemont Hospital

Collaborator

Trials

102

Recruited

38,300+

Queen Alexandra Centre for Children's Health, Victoria

Collaborator

Trials

1

Recruited

2,000+

Windsor Regional Hospital

Collaborator

Trials

6

Recruited

8,600+

Health Sciences Centre, Winnipeg, Manitoba

Collaborator

Trials

18

Recruited

11,600+

Hamilton Health Sciences Centre

Collaborator

Trials

1

Recruited

2,000+

Findings from Research

The Global Trigger Tool (GTT) demonstrated moderate accuracy in identifying adverse events (AEs) in adult inpatients, with a sensitivity of 0.41 and specificity of 0.68 for all AEs, but showed significantly higher sensitivity (0.85) and specificity (0.88) for more serious AEs classified as harm F-I.

The GTT missed several AEs related to nursing care, indicating that it should be used alongside other measurement strategies to provide a comprehensive assessment of patient safety and improve healthcare quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of the Global Trigger Tool is higher for the identification of adverse events of greater harm: a diagnostic test study. Moraes, SM., Ferrari, TCA., Beleigoli, A.[2023]

In a study of 468 stroke patients, severe adverse events were found to be significantly more common in those who died compared to those who were discharged, with 76.5% of events occurring in deceased patients.

Major adverse events, particularly those related to medical procedures and nursing activities, were strongly associated with death, highlighting the need for improved safety measures in stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and death in stroke patients admitted to the emergency department of a tertiary university hospital. Daud-Gallotti, R., Dutilh Novaes, HM., Lorenzi, MC., et al.[2019]

The study analyzed 1543 reported severe adverse events from clinical research protocols at Hospital de Clínicas de Porto Alegre, highlighting the types and classifications of these incidents.

This preliminary evaluation provides important insights into the safety concerns associated with clinical trials across various medical specialties, emphasizing the need for ongoing monitoring and ethical oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Severe adverse effects: evaluation in research protocols used at a university hospital]. Goldim, JR., Raymundo, MM., Marodin, G., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Network Implementation of Guideline for Early Detection Decreases Age at Cerebral Palsy Diagnosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Early Cerebral Palsy Detection and Intervention. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Age at Referral of Children for Initial Diagnosis of Cerebral Palsy and Rehabilitation: Current Practices. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation of Early Diagnosis and Intervention Guidelines for Cerebral Palsy in a High-Risk Infant Follow-Up Clinic. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Early Intervention for Children Aged 0 to 2 Years With or at High Risk of Cerebral Palsy: International Clinical Practice Guideline Based on Systematic Reviews. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Using risk management files to identify and address causative factors associated with adverse events in pediatrics. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The accuracy of the Global Trigger Tool is higher for the identification of adverse events of greater harm: a diagnostic test study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Classification and team response to nonroutine events occurring during pediatric trauma resuscitation. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events and death in stroke patients admitted to the emergency department of a tertiary university hospital. [2019]

10. Brazil pubmed.ncbi.nlm.nih.gov

[Severe adverse effects: evaluation in research protocols used at a university hospital]. [2016]

11. Australia pubmed.ncbi.nlm.nih.gov

Clinical practice of health professionals working in early detection for infants with or at risk of cerebral palsy across New Zealand. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Managing mothers' and fathers' uncertainty during their journey through early neurodevelopmental follow-up for their high-risk infants-A qualitative account. [2023]

13. Australia pubmed.ncbi.nlm.nih.gov

Consensus of physician behaviours to target for early diagnosis of cerebral palsy: A Delphi study. [2021]