Actively Recruiting
CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial
Led by Rigshospitalet, Denmark · Updated on 2023-04-28
500
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm birth with gestational age below 32 weeks or birth weight below 1500 g and clinical concern
- Moderate to severe brain injury including Papile grade 3 to 4 intraventricular hemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation), or other significant neurological condition
- History of neonatal seizures, extracorporeal membrane oxygenation, meningitis, kernicterus, severe hypoglycemia, or neurological risk factors such as brain malformation or increased muscle tone
- Parental concern plus one of the above factors
- Inability to sit independently by 9 months of age
- Presence of hand function asymmetry or crawling asymmetry
- Inability to bear weight through the soles of the feet
- Infants with findings suggesting cerebral palsy emerging in the first year of life
You will not qualify if you...
- Infants with progressive or neurodegenerative disorders
- Infants with genetic disorders not associated with cerebral palsy
- Infants with other disability diagnoses such as Down Syndrome
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University Hospital Aalborg
Aalborg, Denmark, 9000
Actively Recruiting
2
University Hospital Aarhus
Aarhus, Denmark, 8000
Actively Recruiting
3
University Hospital Herlev
Herlev, Denmark, 2730
Actively Recruiting
4
University Hospital Rigshospitalet, Dept. Paediatrics
Copenhagen, Østerbro, Denmark, 2100
Actively Recruiting
Research Team
C
Christina E Hoei-Hansen
CONTACT
L
Lene Weber
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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