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Early Diagnosis Practices for Cerebral Palsy (CP Trial)

N/A

Waitlist Available

Led By Luu Thuy Mai, MD, M.Sc.

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Major congenital malformation and/or significant chromosomal defects affecting development beyond preterm birth

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 18-24 months ca

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the early diagnosis of cerebral palsy in preterm infants by implementing a clinical practice guideline in neonatal follow-up clinics across Canada. The researchers will assess if clinicians are following the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves the adoption of best practice guidelines rather than medication, there are no direct side effects as typically associated with drug trials.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 18-24 months ca

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to 18-24 months ca

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 18-24 months ca for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention : Developmental functioning at 18-24 month CA

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

Secondary study objectives

Implementation : RE-AIM framework - Implementation

Implementation : RE-AIM framework - Maintenance

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention aimExperimental Treatment1 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 aimExperimental Treatment1 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.

0 / 1Eligibility criteria met