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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the early diagnosis of cerebral palsy (CP) in premature infants. Researchers seek to ensure that doctors follow guidelines to detect CP sooner, ideally by 8 months old instead of 11 months. The trial will evaluate whether using two specific assessments together is more effective than using one alone to identify early signs of CP. Infants born before 29 weeks and admitted to certain neonatal units in Canada may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to earlier and more accurate CP diagnoses.

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 prior data suggests that this clinical practice guideline is safe for early diagnosis of cerebral palsy?

Research has shown that diagnosing cerebral palsy (CP) early can be safe and effective with specific assessment tools. Experts recommend diagnosing CP as soon as possible, often within the first few months of a baby's life. Studies have found that these tools can accurately identify CP or a high risk of CP, even in babies as young as 3 months old.

These methods aim to improve outcomes by diagnosing and starting treatment early, taking advantage of a time when the brain is more adaptable. This approach can enhance a child's development.

Overall, the tools for early CP diagnosis are well-established and considered safe, with no significant side effects reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for early diagnosis practices for cerebral palsy because it aims to identify signs of CP at a younger age compared to the current standard, which typically diagnoses children around 11 months old. This trial uses both the general movement assessment and the Hammersmith infant neurological examination, which together may be more effective than the HINE test alone. By potentially lowering the detection age to 8 months, this approach could lead to earlier intervention, which might improve developmental outcomes for children with cerebral palsy.

What evidence suggests that implementing best practices for early diagnosis is effective for cerebral palsy?

This trial will evaluate early diagnosis practices for cerebral palsy. Studies have shown that standardized assessment tools can accurately detect cerebral palsy, or its risk, in infants. Research indicates that combining magnetic resonance imaging (MRI) with other assessments achieves an 86%−89% sensitivity rate in identifying risks. Early diagnosis enables intervention during a critical period when the brain can adapt and develop better, potentially improving a child’s development. Previous findings suggest that using general movement assessments alongside Hammersmith infant neurological examinations identifies early signs of cerebral palsy more effectively than using the latter alone. Standardizing these early detection practices can reduce the age at which cerebral palsy is diagnosed, potentially improving outcomes for children. ^{3 5 6 7 8}

Who Is on the Research Team?

Luu Thuy Mai, MD, M.Sc.

Principal Investigator

CHU Sainte-Justine hospital

Are You a Good Fit for This Trial?

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

Child moved outside Canada prior to first visit in clinic

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

Death prior to first visit in clinic

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9641643/

Early, Accurate Diagnosis and Early Intervention in ...

After 5 months' corrected age, the most predictive tools for detecting risk are magnetic resonance imaging (86%−89% sensitivity) (where safe and feasible), the ...

2.

aacpdm.org

aacpdm.org/publications/care-pathways/early-detection-of-cerebral-palsy

Early Detection of Cerebral Palsy

Cerebral palsy or high-risk of cerebral palsy can now be detected accurately and early using a combination of standardized assessment tools.

3.

nature.com

nature.com/articles/s41372-025-02412-z

Standardizing early cerebral palsy detection in high-risk ...

Standardizing early cerebral palsy detection in high-risk infants: reducing age at diagnosis through a quality improvement initiative.

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06537622/best-practices-fo-early-diagnosis-of-cerebral-palsy?activelyRecruiting=false&page=9&id=480&slug=cerebral-palsy

Best Practices Fo Early Diagnosis of Cerebral Palsy

Early diagnosis and intervention during the optimal window of brain plasticity has the potential to improve developmental functioning. Best ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2818469

Early Neurodevelopmental Assessments for Predicting ...

Early neurodevelopmental assessments were effective in identifying infants with cerebral palsy and predicting its severity.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10614332/

Cerebral Palsy – Early Diagnosis and Intervention Trial

Early screening for CP is increasingly possible and an interim diagnosis of “high risk of CP” is recommended but not currently used in clinical care in Denmark.

7.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00311-6/fulltext

Towards universal early screening for cerebral palsy

International clinical guidelines recommend diagnosis as early as possible using accurate assessment tools in the first months of life. 4 ...

8.

bmjpaedsopen.bmj.com

bmjpaedsopen.bmj.com/content/9/1/e003921

Early detection of cerebral palsy among a high-risk cohort ...

Conclusions Despite pandemic-related disruptions, an accurate diagnosis was possible as early as 3 months of age using the best practice tools.