Cerebral Palsy - Early Diagnosis and Intervention Trial: protocol for the prospective multicentre CP-EDIT study with
Christina Engel Hoei-Hansen1,2, Lene Weber3,4,5, Mette Johansen5,6,7
1Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. christina.hoei-hansen@regionh.dk.
Insights
This study aims to reduce the age of cerebral palsy (CP) diagnosis in infants by implementing early screening and intervention. The CP-EDIT trial investigates the feasibility of early diagnosis and the GO-PLAY intervention for improved infant outcomes.
Area of Science:
- Pediatric Neurology
- Developmental Pediatrics
- Clinical Trials
Background:
- Early diagnosis of cerebral palsy (CP) is crucial for timely intervention during peak neuroplasticity.
- Current mean age at CP diagnosis in Denmark is 13 months, highlighting a need for earlier detection.
- Research suggests early-diagnosis setups can reduce diagnostic age in high-risk infants.
Purpose of the Study:
- To lower the diagnostic age of CP in infants, irrespective of neonatal risk factors.
- To evaluate if the GO-PLAY early intervention program, added to standard care, improves outcomes compared to standard care alone.
- To assess the feasibility of an early diagnosis setup and the GO-PLAY intervention within the CP-EDIT trial.
Main Methods:
- Prospective, multicentre cohort study (CP-EDIT) enrolling approximately 500 infants at risk of CP (age 3-11 months).
- Systematic data collection at inclusion and follow-up of a subset (n=300) until age two.
- The GO-PLAY intervention tested in 80 infants, focusing on early MRI, genetic testing, General Movements Assessment, and parental perspectives.
Main Results:
- The study is designed to assess feasibility and comparative effectiveness, with results pending.
- Investigating early diagnostic tools including MRI, genetic testing, and movement assessments.
- Evaluating parental perspectives on early diagnosis and intervention effectiveness.
Conclusions:
- Early detection and intervention are key to improving outcomes for infants with or at high risk of CP.
- The CP-EDIT trial aims to establish a more efficient pathway for early CP diagnosis and intervention.
- Findings will inform clinical practice regarding early CP identification and management strategies.
Background:
Early diagnosis of cerebral palsy (CP) is important to enable intervention at a time when neuroplasticity is at its highest. Current mean age at diagnosis is 13 months in Denmark. Recent research has documented that an early-diagnosis set-up can lower diagnostic age in high-risk infants. The aim of the current study is to lower diagnostic age of CP regardless of neonatal risk factors. Additionally, we want to investigate if an early intervention program added to standard care is superior to standard care alone.
Methods:
The current multicentre study CP-EDIT (Early Diagnosis and Intervention Trial) with the GO-PLAY intervention included (Goal Oriented ParentaL supported home ActivitY program), aims at testing the feasibility of an early diagnosis set-up and the GO-PLAY early intervention. CP-EDIT is a prospective cohort study, consecutively assessing approximately 500 infants at risk of CP. We will systematically collect data at inclusion (age 3-11 months) and follow a subset of participants (n = 300) with CP or at high risk of CP until the age of two years. The GO-PLAY early intervention will be tested in 80 infants with CP or high risk of CP. Focus is on eight areas related to implementation and perspectives of the families: early cerebral magnetic resonance imaging (MRI), early genetic testing, implementation of the General Movements Assessment method, analysis of the GO-PLAY early intervention, parental perspective of early intervention and early diagnosis, early prediction of CP, and comparative analysis of the Hand Assessment for Infants, Hammersmith Infant Neurological Examination, MRI, and the General Movements method.
Discussion:
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. Additionally, there is a need to accelerate identification in mild or ambiguous cases to facilitate appropriate therapy early. Most 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. The current study aims at improving care of patients with CP even before they have an established diagnosis.
Trial Registration:
ClinicalTrials.gov ID 22013292 (reg. date 31/MAR/2023) for the CP-EDIT cohort and ID 22041835 (reg. date 31/MAR/2023) for the GO-PLAY trial.
