CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial

Summary

Background. Early diagnosis of cerebral palsy is important as intervention becomes possible at a time where neuroplasticity is at the highest. Current mean age at diagnosis is 13 months in Denmark. Recent research has documented that implementation of an early-diagnosis set-up can lower diagnostic age of cerebral palsy. The aim of the current study is to show that the response to the early intervention program added to standard care is superior to standard care alone in a Danish multi-site setting in children from both a newborn and infant detectable risk pathway.

Methods The current study CP-EDIT (Early Diagnosis and Intervention Trial) with the GO-PLAY intervention included (Goal Oriented ParentaL supported home ActivitY program), aims at testing feasibility of an early diagnosis and intervention set-up in four paediatric centers. In a prospective cohort study design, we will consecutively include a total of 500 infants. We will systematically collect data at inclusion and follow a subset of participants with definite cerebral palsy or high risk of cerebral palsy until they are two years of age. The focus is on eight areas related to implementation and the perspective of the families: Early MRI; early genetic testing; implementation of the General Movements Assessment method; early prediction of cerebral palsy; comparative analysis of the Hand Assessment for Infants method and evaluation by Hammersmith Infant Neurological Examination, MRI, and the General Movements method; analysis of the GO-PLAY early intervention; parental perspective of early intervention; and parental perspective of having an early diagnosis.

Discussion Early screening for CP is increasingly possible and an interim diagnosis of "high risk of CP" is recommended but not currently used in our clinical care. There is a need to accelerate identification in mild or ambiguous cases to facilitate appropriate therapy early. The majority of studies on early diagnosis focus on identifying CP in infants below five months corrected age. Little is known about early diagnosis in the 50% of all CP cases that are discernible later in infancy, which is also addressed in this study. The study aims at improving care of patients with cerebral palsy even before they have the diagnosis established.

Conditions

• Cerebral Palsy

Interventions

DIAGNOSTIC_TEST

Early intervention program

At enrollment visit: History and examination, MRI, evaluation of comorbidities, medication and genomic testing. HINE, GMA (if below 5 mo), AIMS, SHAI, PSS and DASS-21 questionnaire. At 6 mo visit: Examination and evaluation of comorbidities, medication and HINE and AIMS At 12 mo visit: Examination and evaluation of comorbidities, medication and HINE, AIMS, HAI, PSS and DASS-21 questionnaire. At 18 mo visit: Examination and evaluation of comorbidities, medication and HINE At 24 mo visit: Examination and evaluation of comorbidities, medication and HINE, PDMS-2, GMFM-66, BSID-IV-cog, MPOC-20 ,PSS, and DASS-21 questionnaire. GMFCS and Mini MACS if CP.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Christina Hoei-Hansen, professor · Department of Paediatrics, University Hospital Rigshospitalet, Denmark

Eligibility

Min Age

3 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-01

Primary Completion

2025-03-31

Completion

2028-03-31

Countries

• Denmark

Study Locations